Links to 1013 Entry-Level Biotechnology & Life Science Jobs

The immunoassay function within R&D is responsible for developing the next generation diagnostic kits for Meridian. The Senior Research Associate will support the development of a new diagnostic device as part of an assay team. Responsible for designing and executing experiments, acquiring data, drawing conclusions for discussion and recommendations. Key Duties: Supports the technical work of a project – execute experiments. Participates in brainstorming discussions and sharing ideas with the team. Presentations – present data during team meetings. Data analysis – review the data generated by a given study and draw conclusions. Documentation ownership – write protocols, reports and any other documentation needed for the support of the project. etc.

Your mission will be to: Job Duties: Composting and grinding of samples for analysis as required. Perform chemical analyses such as protein, moisture, fat, ash, and other components. Prepare sample for analysis according to procedure. Retrieve samples from designated areas (e.g. log-in, sample storage). Perform chemical analyses of macronutrients, micronutrients or other parameters as designated. Extract desired component from sample with appropriate processes so that concentration can be determined. Prepare standards and reagents that are needed for the analysis procedure. Write/label all samples throughout the process so that Client and sample numbers can be tracked. Perform calculations, checking and interpretation of results where applicable. etc.

The incumbent is responsible for performing chemical analysis on food, pharmaceutical, and other sample. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the sample to obtain the required results. The incumbent observes daily activities of departmental personnel ranging from receiving to reporting of results and ensures that analysis is performed correctly. Performs high end analyses with instrumentation (GCMS, LCMS, HS-LCMS, etc.) autonomously. Utilize various instruments such as LCMS, GCMS, HPLC, ICP, ICPMS, and GC to determine concentration of desired balances in the food sample. This position has the responsibilities and authority to identify departures from the quality system or test procedures and document such observation accordance with the prescribed complaint system. etc.

Your mission will be to: Job Duties: Read plates and tubes, as required, to determine the number of organisms in the sample. Record findings on worksheet for verification. Write identification onto plates so that client and sample number can be tracked. Pipette sample solution into tubes or plates according to the analysis process being performed. Pour the agar into plates or tubes to begin the growth process. Prepare sample for analysis by recording, weighing, and blending. Collect plates and place them in the incubator for the specified amount of time and temperature. Prepare media and broth for use in pathogen testing as required. etc.

Performs non-routine technical assignments of substantial variety and complexity. ESSENTIAL FUNCTIONS PERFORMED: Performs assignments and may assist in planning assignments of a non-routine nature for which operational precedents are not fully applicable. Prepares test specimens, adjusts and operates equipment, and records test data, pointing out deviations resulting from equipment malfunction or observational errors. Extracts engineering or other data from various reports, processes the data, and presents the data. Receives technical advice from engineers or supervisor for complex problems. Working overtime may be required for this position. etc.

Performs a variety of complex medical assembly and processing tasks as a production team member, including performing various technical assembly tasks. ESSENTIAL FUNCTIONS PERFORMED: Perform all processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function. Ability to rotate through the assembly line, performing all production assembly operations. Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions. etc.

Performs a variety of medical assembly and processing tasks as a production team member, including performing various technical assembly tasks. ESSENTIAL FUNCTIONS PERFORMED: May include but not limited to performing one or more processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function. Ability to rotate through the assembly line, performing all production assembly operations. Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions. etc.

Performs a variety of complex medical assembly and processing tasks as a production team member, including performing various technical assembly tasks. ESSENTIAL FUNCTIONS PERFORMED: Perform all processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function. Ability to rotate through the assembly line, performing all production assembly operations. Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions. etc.

A Research Associate I (RA I) is responsible for carrying out reagent and assay development activities in the laboratory, under supervision, working to achieve development project goals including data analysis and assay qualification. This is a laboratory position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). Some degree of professional latitude, creativity and self management is expected. DUTIES AND RESPONSIBILITIES: Analyze and prepare reagent and product documentation, organize and procure reagents, perform experiments, analyze data and document results. etc.

MRIGlobal is seeking a highly motivated chemist to join our chemistry program in the Physical Sciences Group. The position will involve providing analytical and logistic support for US Government clients requiring characterization of unknown samples. The position will require the use of a variety of techniques for the identification of unknown materials and impurities/degradants (e.g., GC-MS, LC-MS, DART-MS, Raman, FTIR, XRF, etc.). The chemist may also be responsible for instrument calibration and maintenance, data processing and review, and assisting with drafting monthly or final reports. etc.

The Distribution Associate role plays a critical role in the fulfillment of customer orders through the activities of receiving, picking, packing, and shipping of life science materials. Standing for long periods of time, operating powered industrial equipment and lifting up to 50lbs frequently. etc.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for clean room operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation. Overall, your keen ability to carry out key cell processing and manufacturing procedures will champion the continued development of Miltenyi Biotec products and growing success. etc.

As a Software Engineer I at Minnetronix, you’ll design, implement and test real-time embedded medical device software and supporting applications and prototypes. Working under close engineering supervision on a cross-functional team, you’ll help bring medical devices from concept through development and into production . We have a broad client base so project assignments will span an array of products, be broad in nature, and require creativity and ingenuity. Essential Duties and Responsibilities: Assist in definition, analysis and allocation of requirements. Implement source code that meets product requirements in compliance with applicable coding standards. Contribute to analysis, review and evaluation of design alternatives and failure mode analyses. Assist in the creation and document ation of module-level software architecture and all aspects of software design. Unit test source code using IDE’s, debuggers, emulators, communication analyzers, scopes, and logic analyzers. Install, qualify, and configure development tools and utilities. etc.

Miromatrix has an immediate opening for a highly motivated R&D Operations Technician at our Eden Prairie, MN facility. The term of the position is 6 months based upon a critical business need, with the potential to advance to a full-time role based upon performance during the term of employment. Primary duties include: Performs various support functions using proper procedures to meet cGMP cleaning requirements. Maintains and cleans equipment and the facility; maintains and restocks supplies; strong attention to detail is essential while dealing with multiple tasks. Additional cleaning (i.e., emergency cleanups, construction cleanups, and room set-ups) will need to be performed on an as needed basis. Major responsibilities are preparing, maintaining, and sterilizing supplies and equipment for use in the laboratory. etc.

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts. The anticipated time frame for this assignment is six months. etc.

The incumbent will collaborate closely with Moderna’s process development, analytical development, and process automation teams. The successful candidate must be able to work in a fast-paced and highly dynamic environment, will have relevant academic and or industrial experience in large molecule bioprocessing, and will be able to contribute to both process development and automation related activities. Previous experience with enzymatic reactions, chromatography, and/or tangential flow filtration is preferred. We seek applicants that are proactive, enthusiastic, and show a passion for process development. Applicants should have exceptional time management and communications skills with a strong attention to detail. etc.

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations at the Moderna Norward facility in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently. They will be curious to learn and able to demonstrate a high degree of working flexibly. Here’s What You’ll Do: Safely transport product, equipment and materials (buffers, drug substance) from the warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements in support of the manufacture of mRNA medicines. etc.

The primary responsibilities include performing basic routine analysis in our Inorganic laboratory. Position is responsible for preparing reagents and solutions, setting up laboratory equipment and performing a variety of routine wet chemistry analysis.

The primary responsibilities include sample and reagent preparation, data processing and calculations through use of LIMS. Follows method and SOPs. Performs extractions on Wisconsin DRO/EPA DRO soils and waters, 608 and 8081/8082 pesticides, 8270 base/neutral acids and TCLP samples. Performs dilutions and prepares standards. Uses accelerated solvent extractor to extract appropriate soil samples. Performs maintenance on instruments.

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: Develops business plan for assigned territory that is consistent with Mylan’s sales plans, strategies and objectives. Conducts quality sales presentations to all targeted customers. Achieve quarterly sales goals within territory while adhering to all ethical sales practices and required regulations. Understands and demonstrates targeting principles. Develops pre-call planning strategy for key targets. etc.

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our research and development team as a full-time Research Associate. This position is well suited for those that can accomplish defined work, as well as assist in approaching and solving complex scientific problems. This individual will be responsible for assisting in the generation, production and characterization of novel antimicrobial products. The ideal candidate will be able to independently conduct general microbiological and molecular biology research, and assist in the development of our broader research goals. This individual must be able to communicate effectively in formal and informal settings and be able to work well within a team. Candidates should have prior laboratory experience and be competent at basic molecular biology techniques. etc.

Locus Biosciences is seeking highly motivated applicants to join our research and development team as a full-time Research Technician within the Translational Medicine group. This position is well-suited for highly motivated technicians that have a desire to push product development forward into critical preclinical in vitro and in vivo testing across a variety of therapeutic indications. This individual will work directly with scientists in both Development Translational Medicine as well as the Discovery group to develop and execute in vivo animal models and analyze tissue samples using various molecular and biochemical assays. The ideal candidate will be well organized and have a scientific background as well as experience with microbiology techniques and in running animal models. Candidates must have the ability to manage multiple concurrent projects, but be flexible, adjusting plans as the data dictate. The individual must be able to communicate effectively and be able to work across interdisciplinary teams. etc.

The Quality Control Technician I focuses on the performance of analytical testing activities within the QC Chemistry lab. They are responsible for testing intermediate and finished chemical products, analysing the results of Quality Control testing and comparing results to established specification and customer requirements. In addition, they perform testing and/or review of incoming goods. This position reports to the Quality Control Supervisor/Quality Control Manager. Areas of Responsibility: Completing analytical Quality Control activities for chemical products in accordance with established procedures. Ensuring products tested adhere to established specifications and customer requirements for product release. etc.

We are seeking a highly motivated, positive and bright Technician to join our small company atmosphere with opportunities to learn and grow. This would be a rewarding, challenging and fun opportunity for the right person. Primary Function: Responsible for performing the set-up, calibration, testing, troubleshooting of circuits, components, instruments, optical and mechanical assemblies. Determines and may develop test specifications, methods and procedures from blueprints, drawings and diagrams. Tests and troubleshoots assemblies and Laser systems. etc.

Delivering manufacturing requirements against production schedule within a focused manufacturing operation and/or product segment. Work schedule may include alternate shifts. Participating in manufacturing processes to support new product design transfer, stability program, process development, equipment validations, process validations and investigations and resolution of product/process issues. Performing maintenance and calibration of Manufacturing measuring and monitoring devices as well as maintaining the integrity of work areas. What you will do: Deliver manufacturing requirements and attainment of production schedule for standard inventory, build-to-order, and contract manufacture market products. Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples. Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions. etc.

The Assembly Associate I, Consumables will be responsible for: Building of cassettes for use by Engineering, Development, Clinical Studies, and product sales. Following approved cGMP manufacturing instructions and personnel are required to complete a history record of the lot built per company Quality System. Providing feedback on the processes to assure continuous improvement by noting differences in parts, assemblies, tools, fixtures, or process steps. What you will do: Coordinate with other assembly associates daily in support of integration testing, manual instruction development and production process development. All to support a quality process. Hands-on assembly, test and troubleshooting of system builds and re-work. etc.

Lygos is seeking a Lab Technician/Research Associate candidate to set up, run, clean, and support downstream processing experiments. The successful candidate will have experience with general lab procedures, data interpretation and reporting in a fast paced and dynamic work environment. The candidate will work under the supervision of the Production Specialist. The candidate will be expected to work collaboratively with other team members within DSP (Down Stream Processing) and other departments including molecular biology, downstream processing, and analytical. The Lygos team works closely with all employees to support career development and facilitate the learning of new skill sets. etc.

This is an intermediate experienced engineer/associate position that will play an important role in developing stable cell lines and robust cell culture processes to be used in clinical manufacturing. Experience will dictate the exact title. The position will report to the Manager of Cell Line Development. Essential Job Responsibilities: Develop stable cell lines: Host cell transfection with target plasmid. Minipool screening and single-cell cloning. Shake flask fed-batch studies to support stability studies and top clone selection. etc.

Packaging Line Operator is responsible for tending machines and conveyors at various stages of the packaging line to maintain efficient, continuous packaging of the product for shipment. Essential Functions: Components are in Place and Filled. Sets up assigned station(s) on the line including assembly of basic equipment and preparing materials needed (e.g. bottles, caps, cotton, etc.). Tends/operates station(s) during production run to insure proper operation and keep station filled with supplies or product. Weighs product at various stages of the packaging process. Performs checks/tests required for applicable station(s). Adjusts containers/materials for proper placement and remove defective pieces. Starts and stops equipment when required. Performs hand-packaging and material-handling functions. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. Must be able to work a 12 hour shift schedule of (7pm-7am) rotating shift with potential of night shift. In addition to occasional overtime as needed. ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. etc.

The Quality Control Specialist will join a newly formed Quality Control team and report directly to Quality Control Manager. This position would give you the opportunity to be part of the brand-new Quality Control (QC) Cell Therapy Laboratory and be a key figure in day-to-day operations. The specialist will assist and collaborate with R&D on a successful transfer of analytical methods to QC. In addition to that, the QC Specialist will be performing assays in support of production, product release and stability studies on Marker’s GMP products and drug components, in accordance to the Quality Control Standard Operating Procedure and in compliance to FDA regulations. etc.

We are seeking a talented and highly motivated researcher with experience in molecular and cellular biology to contribute to projects developing stem cell models for drug discovery for a variety of therapeutic areas. The successful candidate will have a thorough understanding of molecular biology with familiarity in human pluripotent stem cells (hiPSCs/hESCs). Additional experience with CRISPR gene editing, assay development, and high throughput screening is preferred. As a member of the stem cell group, you will work alongside stem cell scientists to support the growth of new differentiations, assays, and screens. This is an exciting interdisciplinary role in a dynamic cross-functional team that will contribute directly to the identification of new targets and the design and validation of novel disease-modifying therapeutics. etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

The Specialist, Distribution is a functional role that includes distribution order picking, stocking, packaging, and other material handling and inventory control tasks to ensure timely and accurate shipments are made to our customers using various indicators or signals. To assure team continuity across all warehouse operations, this position may also be required to learn, perform, and or be certified to assist within other areas of Warehouse Operations including material & inventory, traffic, or others as assigned. The role works collaboratively with key business partners to ensure timeliness of execution, appropriate safeguards to protect during transit, and or other. Interacting with Customer Service, Purchasing, Planning, Operations and Material Control to identify and meet business requirements. etc.

This position exists as a support to the manufacturing department. This position labels and delivers all packaging with the correct lot information and ensure that each production team member has the materials that they need to ensure maximum productivity and uptime. What you will do: Label all inner packaging with correct lot information for each machine in operation on a given shift. Apply labels to outer and intermediate packaging for all products on a given shift. Deliver materials as required to each machine in operation on a given shift. Empty the trash and scrap generated from the production cell over the course of a given shift. Assist the team lead with material movement inside the department, including raw materials, finished goods, and WIP materials. etc.

Our imaging services are growing rapidly, and we are currently seeking a full-time, office-based Imaging Project Coordinator to join our team. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities: Compile and maintain project-specific status reports and project timelines associated with imaging studies; Maintain inventory of imaging supplies for study sites; and Interact with study sites and internal associates. etc.

The Women’s Health Customer Representative supports customers by providing clinical information on our Company's products, as well as education, clinical training programs, and resources. They do this to support customer needs in an effort to help the provider or system meet the goals of their patients. The Women’s Health Customer Representative is the primary point of contact for a variety of customers within their assigned geography. These customers may include: health care providers such as physicians, nurses, pharmacists as well as quality directors, LARC initiative personnel and office managers. Within their geography there are a diverse set of health care locations that they will call upon in order to execute their role including: clinics, health departments, integrated delivery systems, and hospitals. etc.

The Center for Radiological Research is seeking a technician to work with scientists studying the health hazards and antimicrobial efficacy of ultraviolet light. They will gain experience in immunohistochemistry, animal handling and husbandry, and ultraviolet exposure techniques. The primary work location will be at the Radiological Research Accelerator Facility at the Columbia University Nevis Laboratories in Irvington, NY. Occasional work at the Columbia University Irving Medical Center may be required.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. etc.

Job Summary: Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

The Analyst I is responsible for preparation of reagents and solutions as well as sample processing under required regulatory documentation. Analyzes data, interprets results, and contributes to troubleshooting activities, such inventory of chemicals, washing glassware, waste disposal and/or general cleanup. May provide basic training for other laboratory personnel. Process and/or analyze samples. Prepare and label laboratory solutions. Perform and/or verify calculations related to reagent preparation and/or sample analysis. Conduct sample inventory and verify sample identities. Review information and documentation for accuracy. Prepare study records for archive. Independently create basic experiment plans. etc.

The Analyst II is responsible for preparation of reagents and solutions as well as sample processing under required regulatory documentation. Analyzes data, interprets results, and contributes to troubleshooting activities, such inventory of chemicals, washing glassware, waste disposal and/or general cleanup. May provide basic training for other laboratory personnel. Process and/or analyze samples. Prepare and label laboratory solutions. Perform and/or verify calculations related to reagent preparation and/or sample analysis. Conduct sample inventory and verify sample identities. Review information and documentation for accuracy. Prepare study records for archive. Independently create basic experiment plans. Process and summarize data using applicable software. etc.

Provide administrative support related to writing reports, test procedures, filing, and preparation of studies for archival. Works on assignments that are complex in nature in which considerable judgment and initiative are required in resolving problems and making recommendations. ESSENTIAL FUNCTIONS: Works in conjunction with Management/PSI and Quality to ensure report writing process is accurate and completed in a timely manner. Provides support for creation of reports, tables, and transmittals to be published by Management/PSI. Prepares studies for archival based on scientific department requirements. etc.

The Analyst II will be responsible to help extend our active hours by working a 2nd shift. Primary duties are preparation of reagents and solutions under required regulatory documentation, initiating and finishing sample analysis, monitoring results, contributing to troubleshooting activities. Other duties may include performing chemical inventory, and general laboratory activities such as washing glassware, waste disposal and/or general cleanup. With demonstrated progress and initiative, the candidate will also have opportunities for learning other value-added skills. Key Job Responsibilities: Typical responsibilities may include, but are not limited to, the following: Prepare and label laboratory solutions or buffers. Perform and/or verify calculations related to reagent preparation and/or sample analysis. etc.

The in vivo pharmacology group is seeking an experienced and motivated Research Associate to join the growing team in Kite Emeryville. The candidate will join an established group, playing a key role in generating in vivo data in support of multiple programs utilizing engineered human T cells with chimeric antigen receptors (CARs). Responsibilities will include, but are not limited to: Perform in vivo studies to evaluate the efficacy of engineered T cells in mouse tumor models. Establish tumor models through SQ or IV inoculation, administer T cells IV, and dose mice with multiple agents IP or PO. Monitor in-life study measurements (tumor volume/burden, body weight), and enter data in associated software programs. etc.

Krystal Biotech, Inc is seeking a highly motivated and dynamic GMP Manufacturing Associate to support launch of and manufacturing at our Pittsburgh GMP facility. The ideal candidate will have foundation experience in upstream and/or downstream biologics or gene therapy manufacturing. Responsibilities will include, but are not limited to, the following: Develop and execute SOPs. Execute and report IQ/OQ for equipment. Operate and maintain manufacturing equipment. Perform process for manufacturing drug product for clinical trials. Clean and maintain GMP facility. Engage with process development team for tech transfer of improvements/scale up. etc.

Lead, train, and direct the daily activities of the Packaging/Manufacturing Departments by following all applicable Standard Operating Procedures/cGMP’s as well as maintain a safe work environment. Key Duties & Responsibilities: Supervise day to day operations of Manufacturing/Packaging. Assist with daily planning and scheduling to ensure proper workflow. Monitor, organize, and execute all functions associated with packaging of pharmaceutical commercial products and assuring compliance with cGMP, SOP, FDA, DEA, and OSHA rules and regulations. Work directly with management and group leaders to ensure appropriate follow through of the weekly planning schedule. etc.

Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product. JOB RESPONSIBILITIES: Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Granulators, Blenders, Mills, Tablet Presses, Tablet Coaters and Packaging. etc.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards. JOB RESPONSIBILITIES: Daily activities include review of documentation generated during method development, method validation, stability testing, routine testing and other analyses. The individual will interface with their supervisor, the analytical groups and QA on a daily basis. etc.

Person exhibits aptitude in assisting in the development of topical product pharmaceutical formulations, as well as meeting timelines for the department. JOB RESPONSIBILITIES: Assist in the development of broad range of topical product pharmaceutical formulations including gels, creams, solutions and ointments. Develop pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts. Contribute and support the analytical efforts and interpretation of data generated from experimental batches. Write technical documents to support regulatory submissions and technical transfers. Interact cross departmentally and provide technical guidance to achieve company objectives. etc.

The following duties are normal for this position; however, they are not to be construed as exclusive or all-inclusive. Other duties may be required and assigned. Essential Duties and Other Responsibilities: Prepare quotations for protocols, bid requests, study revisions, and additions’ using the company’s pricing tools. Complete budget to actual reconciliations at predetermined time points over the course of awarded studies. Assist in making recommendations on desirable proposals based on established financial and operational criteria, as required. etc.

The primary responsibility of this individual is to maintain the overall health and well-being of the rabbits including cage and facility maintenance. This would include the feeding and watering of rabbits, administering treatments, as well as swapping, cleaning, disinfecting, and sanitizing all animal housing units and animal facilities. Responsibilities Include (but are not limited to): Feeding, watering, and administering treatments, including observing and reporting any signs of disease/illness and help to treat minor cases of such findings. Scraping, chipping, and dusting, animal caging units. Swapping/rotating animal. Caging units. Disassembling/assembling, cleaning, disinfecting, and sanitizing all animal caging units including feeders, water bottles, and enrichment items. etc.

This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products. Work on a team of 6 or more analysts. No direct reports. No purchase approval or budget responsibilities. Responsibilities: Perform accurate and timely analysis of in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements. Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution. Document all laboratory testing and maintain accurate and legible notebooks and records. Peer review of data, reports and notebooks. etc.

Complete in-process, final inspection of medical devices and review DHR and record QC Chemistry and Microbiology results. Responsibilities: Read work instructions to complete in-process and final inspections. Use a wide assortment of QC inspection instruments to assure components and devices are manufactured and are functioning in accordance to specifications. Use simple test equipment and record data and interpret its pass/fail status. etc.

The Machine Operator I is responsible for the setup and operation of standard packaging machinery in the packaging department. This includes working with and monitoring other packaging personnel to complete equipment set up and operation required by the department schedule. Machine Operators must comply with regulatory requirements, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and Manufacturing Process Records (MPR). They will perform all processes as required to fill, label, print, tray seal, pouch, final package, and inspect any Lifecore product; document completed work during packaging of final product; continually practice proper precautions and procedures when working with equipment and handling chemicals; participate in the review of batch records, procedures, and practices to help ensure the safety of all Lifecore products as well as personnel; identify and communicate quality issues to supervisor; acquire and maintain cleanroom and gowning qualification as required. etc.

Icagen’s facility in Durham, North Carolina currently has an opening for a talented scientist to join our Molecular Biology team. This is a full-time, laboratory-based position offering an opportunity to play key roles in identifying novel drug candidates and advancing drug development projects. The ideal candidate will have experience in a broad set of cellular and molecular biology techniques with a fundamental understanding of molecular biology. The successful candidate will be capable of managing multiple projects simultaneously while working as part of a core team. The work will be fast-paced and process-oriented in a dynamic environment which is predicated upon continuous improvement where everyone is encouraged to contribute to improving laboratory efficiency. etc.

The Associate Engineer / Senior Associate Engineer works within cross-functional teams to develop processes for the manufacturing of novel particles for engineered drug delivery. Specific Duties, Activities, and Responsibilities: Work with team of engineers and technicians to manufacture materials to support preclinical and clinical R&D projects. Serve as manufacturing representative for one or more R&D project teams to assist in process development activities to ensure adequate material supplies to meet project objectives. Support R&D project teams through the use of process engineering tool such process mapping, Cause and Effect Diagrams, pFMEA and basic Six Sigma tools. Assist project teams in the transition for lab scale to commercial scale manufacturing. etc.

At Hovione, a Process Engineer's job mission is to ensure the best process engineering knowledge is applied in scaling up chemical and spray drying projects to maximize customer satisfaction ad Hovione's interests and in compliance with all Federal, State, Local and internal policies. It also includes the development of process engineering technical skills to increase the knowledge and offering on the best and state of the art technologies used in the industry. You will be responsible for: Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with best known practices ensuring cGMP compliance. Contribute to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assure that all identified hazards are addressed prior to performing any activities within operations. Plan and design methods to improve efficiency in production. etc.

KEY RESPONSIBILITIES: Responsible for culture of primary human cells for purposes of cell expansion, characterization, and tissue engineering. Perform qRT-PCR to screen donor cells. Aseptic compounding and aliquoting media and buffers. Construct, launch and maintain bioreactors that are used to grow engineered vascular tissues. Perform cell-based assays. Verify process data, protocols, and manage supporting documents. Additional duties will include support of routine lab activities, equipment management, lab maintenance, preparation of experimental materials and protocols, and ensuring good documentation practices for all activities performed. Schedule flexibility required for some occasional cell culture activities needed outside of standard weekday business hours (e.g. weekend cell culture maintenance activities). etc.

The Setup Technician supports the Production operation by setting tools and turn over to production ready for startup. The Setup Technician is required to participate in daily meetings to ensure job accuracy and priorities. Essential Duties & Responsibilities: Train with the Senior Process Technician. Train on Robotics and End of Arm Setup. Assure GMP’s, safety standards and procedures are followed per company policies. Responsible for reviewing crossover priorities and schedule with supervisor each morning. Working from molding crossover, obtain all required elements for priority job including documentation. Verify full last shot and samples of any cavities that were blocked from tool work order packet are collected, verify this represents all cavities and then have Process Tech shut down press. etc.

The Service Hub Technician is responsible for triaging devices where critical decisions are made on the PCI, repair, updating of service record, tracking labor and material as well as updating and printing of a Service Report that is returned with the repaired device. This person must interpret and edit the repair results into device tracking system (Oracle) so that the complaint is addressed, results are technically accurate and include all required elements ensuring that the customer understands the analysis/repair activity.  Communicates with other Repair Technicians as required to clarify repair results. Essential Duties & Responsibilities: Will perform routine and complex work related to the repair and refurbished of medical devices. Troubleshoot and analyze customer device returns to problem solve root cause issues. May perform troubleshooting and repair of devices onsite at customer location. etc.

Histologists at IDEXX perform dissection, grossing, embedding, microtomy, special staining, and complex tissue diagnostics on veterinary samples from dogs, cats, birds, reptiles, and all other pets big and small. Are you looking to make a difference in the lives of pets? The pet owner counts on it! ​Who should reach out? If you have specific experience in dissection, embedding, cutting, grossing or special stains. Complex Tissue a PLUS. If you desire a role as a coordinator, lab tech, leader or trainer - you will be a contributor to a team focused on operational excellence and the sharing of best practices, our team of laboratory professionals are dedicated, driven and results-oriented. This is a laboratory, so there is potential exposure to biohazards, agents known to cause zoonotic diseases, and hazardous chemicals. etc.

iFyber is seeking a research technician to assist with R&D projects at the interface between chemistry, biology, and material science. iFyber serves clients in the regenerative medicine, medical device, diagnostics, and antimicrobial industries. The person in this position will support a variety of programs that will require experience and/or the ability to pick up bench skills related to microbiology and chemistry. Duties and Responsibilities: Conduct experimental tasks both independently. Follow established protocols and work with senior staff to adapt or design new protocols. Document information in laboratory notebooks and MS Word, Excel, and PowerPoint. Report results via verbal, written, and graphical communication. etc.

The primary purpose of this role is to perform assembly and inspection operations over a range of new products and/or processes. Will support non-cyclical work which may include prototypes and pre-production lots in preparation for validation, clinical trials or transfers. Will also support multiple builds within the facility including lab and cleanroom environments. With guidance from Engineering on projects and using work procedures, this role provides support to the Engineering teams to meet various deadlines. May provide support to other team members or provide input to the Engineers on assembly, processes, and build/quality documentation. etc.

Integrated DNA Technologies, Inc. (IDT) is in the business of moving science forward. We are scientists working for scientists. Our innovative tools and solutions for genomics applications are breaking down barriers and inspiring others to dream big and achieve breakthroughs. Every lab has its own responsibilities and plays a crucial part in IDT’s success. Our entry-level scientific lab-based positions are split between three sub-titles, Synthesis, Purification, and Formulation. More detailed descriptions of each can be found below: The Technician II (Synthesis) synthesizes custom oligonucleotides according to the customer’s order. This generally includes synthesis, cleavage, deprotection and QC sampling of the products being made. The Technician II (Purification) purifies custom oligonucleotides according to the customer’s order. This generally includes the sorting, purification, and QC sampling of the products being made. The Technician II (Formulation) formulates custom oligonucleotides according to the customer’s specifications. This generally includes quantification, final packaging, and QC sampling of the products being made. etc.

Invenra is seeking an enthusiastic and creative Research Associate or Senior Research Associate with a strong background in molecular biology and protein engineering techniques. This individual will have the freedom to explore new technologies and innovations that can revolutionize Invenra’s current platforms. As part of the Innovation group, the successful applicant will work as part of a team that seeks to improve the efficiency or quality of immune-oncology drug discovery. Details of the job include cutting-edge library construction, recombinant protein expression, developing and optimizing various display strategies, and protein binding experiments. The position requires excellent scientific and problem-solving skills, creative thinking, the ability to try new things, and an enthusiasm for science. etc.

At Invitae, we have highly automated labs that process samples 7 days a week. To sustain volume growth and maintain high caliber instrument reliability, we are hiring an Automation Support Engineer to join the operations team. The key responsibility of the Automation Support Engineer is to provide support to the clinical lab automation and processes. The work requires excellent attention to detail, effective written and verbal communication skills, the ability to multiple tasks, and prioritize time sensitive tasks. What you will do: Provide prompt troubleshooting support to laboratory operations and escalate situations as needed to subject matter experts in, computing, automation, and laboratory processing. Support laboratory processes by troubleshooting errors related, but not limited to laboratory robotics and LIMS communication. etc.

We are seeking a data analyst to join our team. Responsibilities will include monitoring our product pipeline using custom software tools with the goal of assuring samples move through smoothly. Candidates should have experience with UNIX. They are expected to take initiative to automate tasks and troubleshoot the production process through detail-oriented analysis. An important part of this job is to be able to clearly communicate technical findings to non-technical teammates. etc.

What you will do: You will get exposure to the proven winning Stryker Trauma culture that delivers Industry leading results in all market segments. You will receive best-in-class formal Trauma training on product portfolio and selling skills which includes on-the-job training in the operating room. You’ll become an expert on surgical procedures by observing well-over 300 cases in your first year. You will develop well-rounded field exposure to prepare you in all aspects of the selling/ servicing process when a territory opportunity arises. You will develop a high level of competency in Orthopaedic surgical needs and procedures becoming a valuable member of the surgical team and positively impacting surgical outcomes. etc.

We are seeking a motivated and versatile individual to join our Manufacturing group in an individual contributor, bench Scientist position. The successful candidate will work closely with other scientists in an interdisciplinary team environment to help optimize our solid-phase oligonucleotide manufacturing process, to make improvements to the synthesis of small molecules that make up our supply chain, and to aid in analytical investigations. The candidate should possess a strong work ethic, excellent communication skills, and a demonstrated record of success in a chemical laboratory setting. RESPONSIBILITIES: Optimize manufacturing and purification processes for the solid-phase synthesis of oligonucleotides and oligonucleotide conjugates. Investigate raw material and process-related impurities. etc.

Just is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated scientist to join a fast-paced, collaborative, and multidisciplinary team. As a member of the High Throughput Analytical group, you will support process development through application of H/UPLC and CE methodologies. Additional experience with other analytical techniques as well liquid handling robotics is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. etc.

Just is seeking a highly motivated Commissioning, Qualification & Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead the process equipment and utilities commissioning, qualification and validation activities required for late-stage clinical and commercial biologics manufacturing. This comprises all phases of implementation, including ownership of key deliverables such as risk assessments, user requirements specifications, functional and design specifications. The selected candidate will also be responsible for commissioning and qualification protocol generation and execution as well as validation summary reports. Additional job responsibilities will include periodic review and requalification of validated equipment and systems to verify compliance with appropriate regulations and maintaining required change control procedures and impact assessments. etc.

Just is seeking a highly motivated entry-level manufacturing Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use under cGMP conditions. Under direct/moderate supervision, job responsibilities include set-up, operation, and maintenance of disposable-based manufacturing equipment; execution of manufacturing process operations; and assisting in general lab operations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation. etc.

Just is seeking a highly motivated process engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to develop mathematical modeling and simulation tools for clinical and commercial biologics manufacturing, data analysis and visualization, empirical and numerical algorithm development, and conveyance of modeling insights through written reports and presentations. The selected candidate will also be responsible for performing bioprocess modeling, writing and revising computer programs, and generating technical reports or documentation. In addition, this team member will gain an understanding of new manufacturing technologies and equipment, including disposable-based systems and continuous processing technologies for a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility. etc.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. etc.

Open position available in the rapid analytics testing group. Responsible for analytical testing of client samples. Testing may include using client-based methods or some method development. Ideal candidate is able to quickly and accurately generate results. Technical writing skills are a plus. Job Requirements: Familiarity with biophysical and protein characterization techniques, such as: SV-AUC, CD, DSC, FTIR, HPLC, UV-Vis. Design and execution of experiments. Routine statistical analysis on generated data sets using JMP or equivalent statistical software. Attention to detail in documentation of experiments in electronic laboratory notebooks. etc.

Job Summary: Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

The Process Scientist/Engineer I represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities. etc.

The successful candidate requires the following knowledge, skills and abilities: One to three years of applicable hands on experience in Plate Based methods. Additional experience in one or more of the following fields: HPLC/UPLC, capillary electrophoresis, spectroscopy or biophysical characterization methods. Good interpersonal skills, the ability to work individually or as part of a team, and problem solving capabilities of standard laboratory techniques. Have strong oral communication skills. In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines. GMP experience a plus. etc.

Essential Functions: Assist in the transfer, development, and optimization of customer programs. Independent operation of instrumentation in the PD laboratories. Assist in conducting, data plotting and reporting the results of laboratory experiments. Monitor ongoing experiments for any unusual occurrences. Maintenance of lab equipment, supplies and records. Execution of basic experimental protocols. Maintaining detailed laboratory notebooks following FDBT procedures. Perform all other duties as assigned. etc.

Responsibilities include: Case Analysis -- Efficiently analyzes all data (ABI, NG, Exome, Exon Array, MLPA, qPCR, Genome Array, etc.) and completes all primary analysis related steps according to standard procedures. Performs at a consistent level of analysis by completing a reasonable number of analysis steps with minimal errors. Reliably identifies variants meeting confirmation criteria and sends them for confirmation using appropriate methods, as applicable. Aims to identify novel situations and seek prompt and appropriate advice on how to proceed. Makes sure all relevant aspects of a case are complete and either sends them to review or logs them out, as appropriate. etc.

Responsibilities include: Learns and follows the established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors and test managers, and record-keeping. Adheres to quality control policies; documents all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed. Identifies problems that may adversely affect test performance, take authorized corrective action, and notifies key individuals. Detects when test performance is not within acceptable levels, and documents all corrective action. etc.

Responsibilities include: Learns and follows the established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors and test managers, and record-keeping. Adheres to quality control policies; documents all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed. Identifies problems that may adversely affect test performance, take authorized corrective action, and notifies key individuals. Detects when test performance is not within acceptable levels, and documents all corrective action. etc.

Gilead Sciences is seeking a Sr. Research Associate I with experience in protein purification process development to support operations at our biologic’s development and manufacturing site in Oceanside California. Specific Responsibilities and skills for Position: The successful candidate will have a working understanding of downstream process development including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance. The ability to demonstrate hands on experience in several of these areas is expected. Experience with multiple modalities (monoclonal antibodies, antibody drug conjugates, virus particles) produced in microbial and mammalian expression systems is a plus. The candidate is expected to work effectively within the purification team to help design and execute experiments supporting process definition, optimization, and characterization with an increasing level of independence. etc.

To realize our dream of building a next-generation organism company, we must ensure that quality is maintained during all stages of our projects, through to the successful deployment of our organisms and processes. Therefore, we’re seeking a QA/QC Engineer with chemical laboratory experience to help define product specification and maintain a Quality Management System. Plus, you’ll ensure that Ginkgo, our customers, and our contract manufacturers have the necessary methods and processes in place, so that we maintain compliance across any required regulatory standard and consistently meet the defined product and process specifications. Responsibilities: Develop, validate, and execute analytical methods, focusing primarily on accurate and precise quantitation. Perform QA/QC data collection, data integration, and data archiving, with the use of Ginkgo’s proprietary LIMS (laboratory information management system). etc.

We’re seeking highly motivated Medical Technologists to perform routine testing in our high-complexity CLIA laboratory. With a strong focus on quality, accuracy, and efficiency, you’ll be responsible for accessioning received samples, and completing quality control, calibration, maintenance, and proficiency testing in accordance with current laboratory procedures. As a member of Ginkgo’s Clinical Laboratory Operations Team, our Medical Technologists will have a key role in ensuring the success of this important initiative. Please note: this is a fixed-term contractor role for the night shift in our rotation. Anticipated hours are 8:00pm - 8:00am on a "4 days on / 4 days off" shift schedule (which will require some weekend hours). etc.

Job Duties: Responsible for strategic and operational activities of clinical research studies in blood cancer metabolism to ensure adherence to intended timelines and achievements of study goals, while ensuring quality by FDA, EMEA, ICH and GCP guidelines. Facilitating interdisciplinary activities, participating in the clinical trial working group (CTWG), Site Management Team (SMT), and internal team meetings to meet the goals and established timelines. Providing oversight in clinical research Organization (CRO), Central labs and other external vendors to ensure deliverables are met and methods of communication are developed to facilitate an efficient workflow. Providing oversight of activities related to safety reporting compliance. Provide study tracking support (CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates, as requested. Provide coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples. etc.

Job Duties: Providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Performing hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages. Performing overall quality of the assigned documents and dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. Reviewing the eCTD compliance of dossier-relevant R&D documents/reports from technical perspective. Supporting the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities. etc.

Job Duties: Provide technical support in developing, authoring, and executing the Commissioning, Installation and Qualification protocols for the chromatography skids and other supporting equipment that are used in the production of drug. Develop, Implement and Install filter integrity testing methods to available automated Filter Integrity Testers (FITs) available on site to verify the integral of the vent filters that will used in the process for WFI Tanks, Autoclaves, supply clean compressed air and as required. Prepare protocols and reports for Validation Project Plan, Validation Master Plan, IQ, OQ, OQ, Traceability Matrix, Engineering test Plans, and Commissioning test strategies following the site Good Data and Documentation Practices (GDP) during protocol execution for qualifying the system or facility. etc.

Job duties: Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing, descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. etc.

As an Equipment Engineering Technician, you are responsible for supporting laboratory equipment management procedures, in alignment to our internal Quality Management System, to ensure superior performance within Laboratory Operations. This will include global laboratory equipment support, sustainment, and operations activities across Production/Clinical, Product Development, Research and Development laboratories, in accordance with CLIA, cGMP and/or GLP guidelines. You Will: Support global laboratory equipment documentation by maintaining internal equipment records into our database/repository. Assist with internal laboratory equipment inventory processes and procedures. etc.

The primary role of the Research Associate is to be responsible for the execution of established histology, and next-generation sequencing assays in the GMP Next Generation Sequencing (NGS) laboratory. This team is responsible for the GMP compliant processing of cancer patient samples through nucleic acid extraction and next generation sequencing. The ideal candidate will have patient-centric approach and experience in a regulated environment (CLIA/CAP, cGMP) and will be expected to maintain batch record reports, consumable inventory, equipment maintenance and calibration to maintain quality control and compliance. Individuals with experience as a Clinical Lab Technologist or Molecular Technologist are encouraged to apply. etc.

The Research Biology group at Harpoon Therapeutics seeks a Research Associate to join our team. Responsibilities include testing of samples in support of both preclinical development and clinical programs, assay development and optimization, and collection of data in support of regulatory filings. Applicants should be capable of working flexibly and expeditiously in a collaborative, innovative and inspiring environment. The ideal candidate will have experience with mammalian cell culture, stable cell line generation, luciferase assays, flow cytometry, and bioassay automation. Good communication skills, good planning, and an ability to meet deadlines are essential. etc.

The Assembler II performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. Cross-trained to perform specialty functions in the following areas: brazing, final testing, charging or wiring. Promotes Helmer values as demonstrated in personal productivity and quality of work, management of internal/external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage and support team initiatives. Comply with workplace safety procedures. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. etc.

The Fabrication Technician: Operates and maintains the laser, Turret Punch, CNC press brakes or panel bender. Will be cross-trained to perform responsibilities on any of these machines. etc.

The Assembler I - Clean & Pack: Performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. May clean and pack units. etc.

The Sustaining Mechanical Product Support Engineer 1: Provides product support to Manufacturing and Sustaining Engineering departments through the development, documentation and production support for Helmer product portfolio. Support projects, specification updates and engineering requirements based on product and stakeholder requirements. Enhance part and product design, quality, manufacturability, and serviceability through sustainment and continued improvement of mechanical designs including assembly/component design and testing, tolerance stack, non-conforming product evaluation and value engineering. etc.

The successful and highly motivated candidate will support the in vivo pharmacology research program and contribute to the multidisciplinary research team by designing and executing in vivo studies to determine pharmacokinetics and pharmacodynamics relationships and efficacy of optimized leads. Position Requirements: ESSENTIAL DUTIES AND RESPONSIBILITIES: Conduct in vivo studies in mouse and/or rat models to assess pharmacological characteristics of preclinical drug candidates. Daily dosing (po, iv, ip) of preclinical drug candidates to mice or rats, followed by blood and tissue collection for pharmacokinetic or pharmacodynamic analyses. Tumor implantation and measurement for long-term efficacy and pharmacodynamic studies. Use of aseptic techniques to grow and scale up tumor cells for implantation in mouse models. etc.

As a packaging technician you will perform filling, kitting, and labeling functions. Key Responsibilities: Assist in the setup and running of automated liquid filling, labeling and packaging equipment. Assist in the setup and running of manual liquid and powder portable filling equipment. Perform daily filling, labeling, kitting duties according to the production schedule. Comply with Good Manufacturing Practices (GMP’s) and Quality Systems Regulations (QSR). General organization of filling, labeling and packaging tasks. Inspect all materials being issued to and returning from shop orders. Accurately count and return all materials. Maintain supplies for the CER, and packaging areas. etc.

Advanced Quality Technician reports to the Quality Control Manager and is responsible for in-process and final QC testing of Bionostics products. In addition, Advanced Quality Technician participates in instrument validations, performs lab maintenance activities, initiates collaborations, monitors laboratory and process inventories, conducts device history record review, and creates certificates of analysis for commercial products. Key Responsibilities: Understands and adheres to all quality technician job requirements. Follows work instructions carefully and demonstrates good documentation practices. Documents results, processes testing, and refers to past batch records when needed. etc.

The technician will work as part of the kitting team under the planning group to complete all tasks related to subassemblies and top-level product kits, packaging and labeling to prepare products for warehousing and/or shipments to customers. Key Responsibilities: Follow SOPs, work instructions and/or drawings to ensure product specifications are met. Assemble, label, and package a wide variety of kits: product components, sub kits and top-level kits. Prepare a collection of product components, sub kits and top-level kits for shipping (Pick to Order, PTO). Prepare demo kits as needed. Stage material for kitting operation. Inspect collection of kit components for expiration dates. Submit daily kitting numbers and associated types (sub kits / top-level kits) to manager at end of shift. etc.

This position is responsible for the developing and or formulation of controls, calibrators, working solutions, and intermediates in the production and development of Bio-Techne's various product lines. You will follow standard operating procedures to manufacture these products and will contribute to the ongoing development of new and existing products to help advance Bio-Techne's evolving portfolio. Key Responsibilities: Assist with preparation and/or development of new products using approved procedures and keep detailed and accurate records. Set up and conduct experiments that help further new product development. Follow standard operating procedures. Perform in process analysis and determine adjustments to bring analytes into specification. etc.

Fate Therapeutics is currently seeking a talented and highly motivated Research Associate with a background in nucleic acid purification and next generation sequencing (NGS) library processing to join a multidisciplinary team dedicated to the discovery and characterization of novel induced pluripotent stem cell (iPSC)-derived cellular therapeutics. The candidate will play a key role in Fate’s Genomics group, executing-based assays in support of Fate’s efforts to generate and characterize best-in-class iPSC-derived cellular therapies. The ideal candidate will be highly collaborative and communicative and have extensive hands-on experience in extracting and purifying DNA and RNA from cells and tissues for use in NGS. This position will require adherence to tight deadlines, strong independent and collaborative research abilities, a high level of organization, and the ability to communicate effectively across multidisciplinary teams. etc.

Duties / Responsibilities: Assist in planning, executing, and documenting studies related to design of novel drug products. Support scale-up and technical transfer of production processes to GMP Manufacturing. Assist with troubleshooting, root cause analysis, and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues. Work cross-functionally across Quality, Research, Clinical, and Manufacturing teams to achieve company goals. Source and maintain relationships with vendors and Contract Manufacturing Organizations. etc.

The Scientist I, Bioinformatics develops novel methods for detecting, reporting and analyzing alterations in tumor DNA and RNA, while optimizing existing methods. The incumbent provides scientific and technical contributions for a designated project on an interdisciplinary team. The Scientist I, Bioinformatics is also responsible for supporting novel biomarker and companion diagnostics development by mining and analyzing various types of data generated during the product development and validation process. etc.

We currently have an opportunity for a Validation Engineer in our Melrose Park Pharmaceutical Manufacturing facility who will provide technical support to operations with equipment/system/process initial validation and equipment/system/process requalifications. This is a first shift position. Weekends and off-shift hours are periodically required. Responsibilities: Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval. Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. etc.

Responsible for performing routine testing of in-process and finished product samples. Monitors environmental conditions in the production and lab areas. Summarizes environmental monitoring and product test results. Provides project support to Scientist and Lead Scientist. Prepares media and reagents and equipment. Responsibilities: Generates new standard operating procedures for microbiology test procedures. Keeps others current as assigned. Performs environmental monitoring for Skan isolators and routine testing of in-process and finished products. Assists Scientist / Lead Scientist with test method validations and special projects. Carries out special projects independently as required and assigned by supervision. Assists with plant equipment requalifications as directed. etc.

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off-line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities: Principal Activities Performed By The Incumbent: Visually inspects products for various defects. Documents work accurately and timely. Complies with current SOP’s and cGMP’s. Sets-up, adjusts, and operates equipment such as inspection machines, cappers, etc.

Your tasks: Maintaining and repairing the physical structure of the building, grounds, injection molding machines and auxiliary equipment. Painting and performing structural repairs to masonry, woodwork, and furnishings of buildings. General cleaning and up keep of buildings, including buffing, dusting, sweeping, mopping, vacuuming, and washing windows. Assist other departments as requested, including moving furniture, unloading, and storing supplies. Perform preventative and corrective maintenance on assigned equipment. Diagnose and repair electrical, hydraulic, and pneumatic control system problems on production machinery, auxiliary equipment and fixtures. Plan, layout and install electrical, hydraulic, and pneumatic systems in support of the fabrication and installation of new equipment and fixtures. etc.

For a contract research organization (Frontage Laboratories, Inc. – Exton, PA): design/develop method transfer, method development, validations, quantitation and structure elucidation; perform high-volume bio-analytical sample analysis; perform data analysis, data quality control (QC) and data interpretation for bio-analytical, PK, PD and ADME studies in regulated environment; utilize and maintain analytical instruments, including Liquid Chromatography Tenderm Mass Spectrometry (LC-MS/MS) and Nuclear Magnetic Resonance (NMR); perform technical work related to the care and use of research animals. etc.

Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment. Candidates with experience in ICP-MS and/or ICP-MS/MS for bioanalytical or other applications are preferred. Duties: Perform high-volume sample analysis and/or data analysis, data QC, and data interpretation. Maintain schedule of projects and timelines. Coordinate study activities with Principle Investigator to ensure efficiency and quality. Aid in the preparation of study summaries and/or reports. etc.

Performs biologics method transfer, method development and validation according to FDA guidance, Frontage SOP and industry practices. Performs sample analysis following SOPs and methods, prepare, review the data package and reports. Provide training and technical guidance to the junior scientists. Provide assistance to project management to ensure meeting the requirements of project quality, and timelines. Provide assistance to the PI/RS to ensure the compliance. etc.

Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including: Support new equipment purchasing, URS creation and or revision, equipment qualification and procedure creation and or revision. Creation and or revision of recipe or methods for various platforms. Review and/or Approve equipment qualification limits. Review Calibration Tolerances and Approve Out of Tolerance Investigations. Develop and approve procedures for new equipment being introduced into the plant. Support new product transfer by creation or revision of the Process Consumable List. etc.

Essential Functions: Responsible for providing engineering, operational and troubleshooting support to facilities, utilities and process equipment as needed. Responsible for monitoring complex equipment and maintaining the equipment with a minimum of downtime. Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs, P&IDs and operations/maintenance procedures for facilities, utilities and process equipment. Responsible for the implementation of process improvements and corrective actions as well as the development of maintenance strategies and equipment life cycle. Responsible to support equipment IQ/OQ/PQ or any other validation startup activity as required. Responsible to support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable. etc.

Reporting to the Sr. Manager, Process Development, this position will be responsible for the upstream processes used in nucleic acid vaccine production including bacterial transformation and fermentation. Incumbent will become proficient in other areas including plasmid purification, transient transfection, and Western blotting in support of the Process Development (PD) laboratory at ITI.

The systems analyst helps support, validate, maintain, and test software and other technology systems. This position participates in design and testing activities with other staff members.

Participate in preparation and submission of regulatory submissions to obtain approval to conduct domestic and international clinical investigations and to seek regulatory approval to commercialize the new and existing devices and their accessories. (IDE supplements, PMA, Annual reports, change notice etc)

Reporting to the analytical chemistry lead this position will be responsible for designing and conducting experiments to develop new analytical methods to support release testing, stability, and characterization of a growing biologics pipeline. This role requires scientific knowledge of a variety of analytical methods, experience in biologics development from early stage to late stage, and familiarity with ICH guidance. Strong interpersonal and communication skills are required.

The Quality Assurance Specialist is responsible for providing Quality Assurance, Quality Control, and Preventative activity support for InGeneron’s Quality Management System. The Quality Assurance Specialist supports operations and other business functions with a focus on compliance to FDA and global quality system regulations and standards.

This position assists in the development of current and future Inova Diagnostic product lines by performing laboratory activities to assist in the development of new assays and/or the identification of potential new biomarkers. This position works under the supervision of the R&D management team and performs lab activities of limited scope, following good laboratory documentation practices and in accordance with Standard Operating Procedures and other Research and Quality System requirements.

Assists with answering phones and the processing of orders. Assists in answering the telephone. Assists Quality Assurance (QS) and Marketing with various projects. Assists in the processing, double checking and obtaining confirmation of sales orders. Assists in the preparation of paper work for the shipment of sales orders domestic and foreign

The Research Associate I (RAI) works under general and specific direction in performing a spectrum of techniques in both cell culture and immunology. The RAI works collaboratively and independently in the lab, solves problems, completes required documentation, and performs general lab duties.

The QA Manufacturing Coordinator has primary responsibility for handling all front office operations as outlined below. Responsibilities: Including but not limited to: Track Change Controls and Deviations that affect manufacturing particularly those that affect MMR(s) and batch records. Change control assignee within Master Control all CC throughout all departments. Coordinate the bulk label process including creation, customer approval and maintenance. Liaison between Coating and QC, reporting batches completed through compression. Perform check of all issued batches to Manufacturing. Review issued commercial batches for coating material needs/maintain Coating Batch Log. Review of various Manufacturing systems (e.g. pest control, purified water). etc.

The Equipment Associate at Cook MyoSite assists in supporting company operations by monitoring and controlling laboratory equipment and production related utilities, as well as assisting with facility related aspects of equipment and the quality system. Responsibilities: Perform the proper receiving, tracking and storing of purchased equipment. Organize and maintain a calibration schedule for equipment. Ensure that all measuring and test equipment used is registered, assigned and marked with a unique internal equipment number for identification. Organize files and maintain all laboratory equipment and facility records. Maintain a calibration schedule utilizing calibration database software. etc.

Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. etc.

Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. etc.

Responsible for preparing the donor, donor area and equipment for the pheresis process. Job Description: Main Responsibilities: Prepares the autopheresis machine for the pheresis process. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. Disconnects the donor when the process is complete. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. etc.

Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. Main Responsibilities: In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. May ensure accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. etc.

DUTIES & RESPONSIBILITIES: Inspect all incoming component shipments to ensure that all applicable specifications are met. Inspect product shipments coming from contract manufacturers/repackagers to ensure that all necessary components meet quality standards. Help trouble-shoot packaging concerns and communicate with contract manufacturers/ repackagers and vendors. Verifies and inspects incoming materials and works accordingly with Quality Assurance to handle any possible discrepancies. Participates in other quality audits when required. Complete and maintain documentation of all items inspected and findings/conclusion of findings. Provide oversight on production line; assist Production Technicians with questions/inquiries about products. etc.

DUTIES AND RESPONSIBILITIES: Install, troubleshoot and repair flow cytometers and Cytek Upgrade products with proficiency in a timely manner. Work professionally and courteously as an individual with Cytek’s customers in continuous support of Cytek’s reputation of service excellence. Identify customer needs and contribute to improvements in Cytek products. Manage the daily schedule to ensure appropriate priority is placed upon urgent customer needs while setting customer expectations for issues of less urgency. Customer Management through telephone technical support, service visit scheduling, product problem information gathering, fault isolation, corrective action, and site visit closure with high quality and efficiency. etc.

This position is accountable for producing and delivering large and small-scale media and buffers to support Upstream and Downstream Manufacturing Operations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Batching and delivering both large and small-scale media and buffer batches. Assisting in the review & creation of operation documents by providing input to technical composition of documents. Effectively demonstrate understanding of GMPs & how it applies to specific responsibilities. Following accurate oral & written procedures in operating production equipment & performing processing steps. Maintain orderliness of process area. etc.

This position is accountable for the execution of procedures for purification manufacturing and support area of manufacturing using SOP’s and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation. ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform in-process testing where applicable. Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps. Provide support to cross-functional teams to meet production or timeline demands. Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice. Provide suggestions for process optimization and efficiency, where applicable. etc.

You will be part of an interdisciplinary team of fermentation scientists and engineers, automation engineers, software engineers, analytical chemists, and molecular biologists to rapidly develop microbial strains to produce high value natural product medicines. The Analytical Chemistry group is an integral part of the Demetrix team, providing the rest of the company with high quality data while maintaining and balancing accuracy, precision, and throughput. As part of the Analytical Chemistry group, you will help us with operations, instrument maintenance and troubleshooting, and development of new methods while fostering an atmosphere of continued improvement and innovation. etc.

Dyne is seeking a talented and highly motivated Research Associate/Senior Research Associate to join our drug discovery team. This member will work closely with other researchers to develop biomarker assays using a variety of innovative technologies. The successful candidate will be ambitious, motivated, an energetic self-starter who enjoys working in a fast-paced environment. We offer a competitive salary with benefits and an opportunity for learning and advancement in an exciting innovative environment. Primary Responsibilities Include: Execute research plans for in vitro/in vivo studies. Analyze data and communicate findings to team members and management. etc.

Hologic is seeking a Research Associate 1 or 2 responsible for designing and performing experiments while collaborating and communicating effectively. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Performs minimally complex experiments with input from supervisor. Understands experimental goal and may provide input to the experimental design. Analyzes data from individual experiment with input from supervisor and documents work in laboratory notebook or report. Able to summarize a group of experiments. Effectively communicates with peers and supervisor. May present data in group meetings. etc.

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment. Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures. Informs Manager on progress of projects, transfer of data, process details, etc.

This is a laboratory testing position with the major responsibilities being daily routine testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support. ESSENTIAL FUNCTIONS: Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Environmental Monitoring Responsibilities: Perform general laboratory duties including, but not limited to: Clean laboratory areas/glassware. Biosafety Cabinet Monthly Cleaning. Safety equipment upkeep including eyewash stations. Transfer and dispose of biohazard waste and chemicals. etc.

We are recruiting a highly motivated researcher to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment. Requirements: Conduct in vivo procedures to evaluate efficacy of AAV gene therapy candidates in rodent models, primarily mice. Perform standard mouse procedures including plasma/serum collection, IV injections, necropsies, and tissue collection in compliance with established protocols. Conduct in life safety assessments: monitor body weight, clinical observations, and survival of mice. etc.

Scope: Be able to manufacture human blood derived oncology drugs per Standard Operating Procedures in a controlled cleanroom environment. Ensures all manufacturing activities are performed under cGMP guide lines. Communicates production deviations/incidents to the supervisor/Manager as soon as it is discovered. Responsibilities: Ensures all training requirements are completed according to Erytech training guidelines. Perform all manufacturing activities according to cGMP guide lines. Record all manufacturing activities in the batch record and Erycaps machine according to the SOP.ng. etc.

Employee Responsibilities: Perform lab-scale downstream processing of vaccine products and process intermediates. Perform assays on vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests. Prepare solutions/reagents. Set-up process equipment for lab-scale experiments. Maintain records and experimental results following good manufacturing practices (GMP). etc.

We are currently seeking candidates for an Associate Scientist with the key duties and skills listed below: Duties and Responsibilities: Consistent compliance with and promotion of all Cayman values, policies, SOPs, and regulations including, but not limited to: Lab Notebook Policy. Safety and regulatory policies. Confidentiality policies. Timely, accurate data entry (AX, SharePoint, P-drive folders, Excel spreadsheets ). Perform assigned tasks with increasing independence: Operate and maintain HPLC, MS, GC, and optical rotation instrumentation. Perform analytical support services for internal chemists and external clients.

The Filling & Assembly Specialist I functions as a member of our Global Supply Chain team to support the discrete manufacturing of our products. Specifically, the Packaging team is responsible for filling and assembly of final products to ensure finished goods inventory is ready and available for customers. This is a temporary 6-month assignment, with hours from 8 AM – 4 PM, Monday – Friday, 37.5 hours per week. Responsibilities: Precision aliquoting and filling of antibody products utilizing liquid handling techniques with strict adherence to SOPs to ensure product quality. Labeling of vials and preparation of packaging for component assembly, adhering to strict quality control guidelines to ensure labeling and packaging meets compliance requirements and standards. Inspecting and packaging product components with manual and/or automated systems to create final products for order fulfillment. Set-up, change-over and operation of labeling, pumping and packaging equipment. Data entry and updating to enable accurate inventory records.

FUJIFILM Cellular Dynamics, Inc is recruiting for a laboratory technician to work in our cell manufacturing and research facility in Madison, WI. This role provides an outstanding opportunity for a dedicated and responsible individual to contribute to maintaining and improving the operations in our facility. Ideal candidates can demonstrate a track record of self-motivation, strong organizational skills, and dedication to their work. Essential Job Functions: Provide lab support for scientific personnel and overall operations. Place orders, maintain inventory, and stock laboratory supplies. Work with laboratory staff to maintain and mature organizational structure. Organize and put away daily shipments consistent with inventory management, housekeeping and safety standards. Perform maintenance on equipment as specified, including minor repairs and cleaning.

We seek a highly motivated bench scientist to focus on autoimmune target ID and validation. The successful candidate will have good prior experience in immune biology, with experience in assay development using immune cell types, including primary cell assays. Using this expertise, the successful candidate will gain experience learning how to apply large single cell and other datasets, as well as functional genomics approaches, towards the identification and validation of new targets. RESPONSIBILITIES: Develop and execute in vitro immune cell assays to functionally validate novel targets. Participate in the interrogation of single cell datasets towards the identification of novel autoimmune targets (prior experience with single cell RNA sequencing is not required).

Centrillion is seeking Laboratory Technicians for their research and development teams. These positions are in a fast-paced, start-up environment, interacting with R&D scientists from a variety of backgrounds, with a heavy focus on molecular biology and biochemistry. Lab technicians will divide their time between hands-on laboratory work, data analysis, and lab organization and maintenance. The selected individuals will be working in a support role toward the development of new genomics technologies. The candidate will work with multiple scientists to assist with a broad range of duties including making buffers, following protocols, developing or adapting new protocols for new needs.

ESSENTIAL JOB RESPONSIBILITIES: Responsible for regulatory project timelines and management of global regulatory submissions. Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines. Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives. Interact with global regulatory leaders and peers to expedite approval of pending registrations. Support internal and external departments to generate protocols and reports for registration purposes. Maintain a "focused urgency" as required by specific events. Recognize potential problems by actively reviewing and analyzing internal and external factors. Assess potential impact and/or applicability to other related areas.

The Maintenance Technician II is responsible for assisting the Facilities and Engineering Manager with the maintenance, quality, and upkeep of the manufacturing, testing, and animal holding facilities, and the equipment and utilities at each location, in support of the manufacture of biological products consistent with the corporate objectives and external, international, and federal regulatory requirements. Responsibilities and Key Duties: Perform preventive maintenance on HVAC, electrical, structural and other non-critical equipment. Assist in the execution of PMs on critical equipment. Perform non-scheduled maintenance, on all non-critical equipment, in a timely manner as requested via the MWO system. Review and document all repairs, alarms and PM activities according to applicable Standard Operating Procedures.

Job Summary: The following are responsibilities related to the Technologist - IVB in Wilmington, MA: Perform daily test article/substance administration, observation and recording of physical signs of species for contracted laboratory studies. Prepare cage tags and individual animal number tags; prepare and autoclave cages. Prepare data forms for routine study procedures. Assist with preparation of data forms for specialized study procedures. Record study parameters as required by protocol. Ensure adequate supply of dosage equipment during the course of study. Assist in ensuring adequate supply of additional study specified materials such as blood collection tubes. Assist in preparation of test agents.

We are seeking a Technician 1 Microbiology for our Biologics Testing Solutions site located in Malvern, PA. The responsibilities of this role will be specific to the Sterile Services division of the Microbiology department. The following are the responsibilities of the Technician 1 Microbiology: Performance of direct inoculation and membrane filtration sterility testing. Performance of direct inoculation and membrane filtration bacteriostasis and fungistasis testing. Growth promotion testing of sterility and other microbiological testing media.

Perform basic Electron Microscopy sample preparation with minimal supervision. Participate in the documentation of all activities as required. May also assist with setting up study files, inventories, and sending reports and study materials. We are seeking an Electron Microscopy Technician I for our Safety Assessment site located Durham, NC. The following are responsibilities related to the Electron Microscopy Technician I: Log in samples and set up study files for each protocol. Trim tissue, process/embed both viral and tissue specimens with supervision. Prepare solutions/reagents, cut thick/thin sections on the ultramicrotome, and stain slides/grids. Copy and send reports, prepare delivery slips, and return materials to the client. Understand and conduct all processes in compliance with Good Laboratory Practice (GLP) regulations, corporate Standard Operating Procedures (SOP), and the protocol.

The job duties: Manufacture of DNA & RNA compounds. Assist Senior Chemists. Prepare test solutions, reagents and ability to carry out reactions, to produce specialized ultra pure DNA/RNA synthesis products. Operate rotary evaporators, chillers, Preform column chromatography: small scale (on the bench) & large scale. Follow SOPs of standard products; report any deviations to Senior Chemists. Communicate with QC & QA department to update/create certificates of analysis. Maintain timely documentation of work. Evaluate data & prepare technical reports. General lab maintenance as necessary.

Duties: Work under the Chief Financial Officer to coordinate accounting and financial operations of the company to project and plan future earnings and expenditures. Apply principles of business finance to analyze financial records and financial operations in order to determine accuracy of financial records, efficiency of operations and effectiveness of budget control and to estimate future revenues and expenditures. Provide strategic analysis and advice to senior management for strategic decision making for entering into joint venture projects with businesses both in China and the United States to set up new production facilities in China, and new warehousing facilities and wholesale outlets in the United States; and Prepare budget reports, as well as long term budget plans with cost analysis and fiscal allocation, and maintain budgeting systems with the company to provide control of expenditures for product development and new business acquisitions and ventures.

This position will manage a wide range of administrative and executive support related tasks and will be able to work independently with little or no supervision. Primary Responsibilities: Assay Development: Design and validate cell-based fluorescence and automated electrophysiology assays to support receptor lead selection. Compound Screening: Execute medium throughout compound screening and follow-up pharmacological evaluation of small molecules on lead chemogenetic receptors. Organization and Communication of Data: Analyze and communicate data in written and oral modalities in both informal and formal settings. Generate and manage meticulous method protocols, data, and analysis reports in a clear and highly organized fashion.

ESSENTIAL DUTIES AND QUALIFICATIONS: Adheres to Standard Operating Procedures (SOPs) and good documentation practices to ensure data integrity and traceability. Perform cell based immunological in vitro methods (e.g., cytotoxicity, HLA-restriction, cell proliferation, ). Perform release testing utilizing a variety of techniques ranging from compendia assays like pH and osmolality to more complex assays like, but not limited to, proliferation and cytotoxicity. Be able to quickly learn various methods and participate in the troubleshooting of assays. Enters observations and results into the appropriate trending databases for periodic analysis and trending.

Our Immunology team is seeking a hands-on scientist at our Cambridge, MA site. This role will play a critical role in supporting the research and development of the Immunology Program. This position will assume a key role in developing and implementing novel immunological assays in support of our proprietary therapeutics through an innovative antibody engineering platform. The position will be developing immunological assays in both cell lines and primary cells for identification and prioritization of therapeutic targets for clinical development. The ideal candidate will have a proven track-record of developing creative and novel immunology-based assays for solving complex biological problems, as well as a broad understanding of therapeutic drug discovery and its applications,

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale-up of production processes and equipment across different manufacturing departments. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments. Essential Duties and Responsibilities: Develop and maintain strong, internal working relationships across ConforMIS. Understand the objectives, responsibilities, and mission of the Operations department and works towards those goals. Prioritize and plan work activities; adapt for changing conditions. Initiation, execution, and documentation of IQ, OQ, & PQ activities. Optimization of manufacturing processes (5S) for Lean Manufacturing.

Performs laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal / external customer satisfaction. Responsibilities: The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured. In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, ).

We are seeking a Lab Assistant to join our Next Generation Sequencing team. Responsibilities: Check inventory and replenish consumable sequencing supplies. Assist in sample sorting and properly distribute them. Maintain laboratory cleanliness. Document and track daily work flow. Help with logistics as needed. Prepare supplies and assist Associate Scientists. etc.

Job Description: Commitment to Safety, by following site safety procedures and utilizing safety equipment as required for daily tasks. Uses batch record instructions, job aids, standard operating procedures, and product specifications to execute production activities. Maintains accurate documentation, records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization). Ability to perform minor troubleshooting and problem solving in areas of set-up of equipment and processes. Ability to perform rework and re-packaging of materials as needed. Ability to work in teams to achieve operational goals while being engaged in the process. Communicating issues and concerns to lead or designee. Performs assembly by following released procedures. etc.

Performs routine set up, operation, minor routine maintenance, preventative maintenance (PM) and troubleshooting of moderately complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Assists with root-cause analysis activities for process or product exceptions. Checks work using prescribed gauges, jigs and fixtures to measure close tolerances. May monitor quality in accordance with statistical process or other control procedures. Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality. etc.

DUTIES: Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle. Develop Device History Files and maintain in a manner consistent with regulatory requirements. Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers. Supports the coordinated integration of new products into Manufacturing / Operations. Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies. Understanding and coaching others on Quality Systems and procedures. etc.

Reporting to a Senior Scientist, Cellular Immunology, we are seeking an experienced, motivated, and highly skilled Cell Biology Associate Scientist. Under scientific and technical supervision, the candidate will perform various cell-based assays and maintain cell lines to contribute to the discovery and development of novel therapeutics at Cabaletta. The position offers growth into additional areas such as translational research and molecular biology, immunology and cell therapy. The position involves both technical and operational responsibilities. etc.

We are seeking an Associate Scientist to support formulation design and development activities within the Formulation team. This role will be responsible for executing oral solid dosage formulation experiments for drug product process development and analytical testing to primarily support early stages of the CDMO projects. Responsibilities: Assists on formulation and drug product process development projects, with an emphasis on early stages of development. Conducts physicochemical characterization and pre-formulation activities. etc.

The Assembly Technician I will be expected to perform basic functions to complete day-to-day production activity. The position requires a highly motivated, positive individual that can work both independently and in a “team” environment. Assembly Technician I level employees will be expected to perform all job duties in the areas they are assigned under basic supervision. They will stay on task and complete quality work with accurate documentation. He/she will be a valuable and trustworthy asset to their work area through quality work of trained processes. This individual must be dedicated to the success of CSI and its quest to continually improve its operations, as well as perform duties to manufacture CSI products, meeting FDA, OSHA, GMP/MDD and ISO compliance requirements. etc.

The Assembler I’s primary function will be to perform light mechanical assembly and electronic assembly tasks as assigned. This includes the repair, assembly or disassembly of various devices. Essential Duties and Responsibilities: Works under direct supervision. Applies basic skills in procedures, techniques, tools, materials and equipment. Performs routine assembly, modification and repair of electronic and electrical assemblies. Working from noncomplex wiring and assembly drawings, operation sheets, engineering specifications, sketches and running sheets, performs initial and basic wiring and assembly operations to complete prototype and production units. Completes wiring connections from one terminal point to another and solders each terminal, working to close tolerances. Uses judgment in reworking or rewiring any unit to bring it within quality control specifications. etc.

The primary purpose of the position will be ensuring that complaints are properly investigated and documented as well as verifying that outgoing units comply with stated guidelines. In addition, the position supports the resolution of customer issues in order to determine the cause of the problem and to initiate the appropriate corrective action. In some cases, formal reports to customer will be required to explain the problem and what was done to correct it. Moreover, the Quality Assurance Engineer will be required to conduct analysis and trending of information and perform inspections on incoming finished goods. etc.

Perform R&D lab technician duties that include testing equipment, building prototype assemblies, building test equipment, and performing associated administrative duties such as lab cleanup and maintenance. Requires only moderate oversight in completing tasks. Essential Functions: Builds R&D test fixtures per specifications provided, providing design assistance and feedback. With minimal supervision, executes test protocols to completion, which includes coordinating the manufacturing and testing of the samples, reviewing the test procedures and data for accuracy and completeness, summarizing and analyzing the data or reviewing summaries for completeness, and informing the appropriate project leader of any questions or unexpected results that arise during testing. etc.

Performs routine production duties associated with various aspects of lens production paying close attention to quality, quantity and efficiency. This position focuses on our Freeform Surfacing area washing lenses, inspecting and taping lenses, matching tools, polishing, running generators, inspecting and coating (backside). Qualifies and inspects product to ensure compliance with CZV specifications and standards. Complies with all safety regulations as well as maintains a clean and safe work environment. etc.

Demonstrate customer service skills and knowledge with a high level of passion and dedication. Demonstrate strong and efficient ability to learn a skill on entry class Coordinate Measuring Machines utilizing mechanical and electronic aptitude. Perform necessary administrative paperwork in complete and accurate manner. Solutions oriented with ability to work independently in a high pressure, fast paced and innovative environment. Travel requirement is 80-100% including international as needed. etc.

We are seeking a Research Associate to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. The successful candidate will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs. etc.

We are seeking a Research Associate II/Senior Research Associate to join an exciting, fast-growing, and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. He or she will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs.

We are seeking a highly motivated, Research Associate to participate in drug discovery programs that lead to the identification of new targets and drug candidates for clinical development. The individual should possess strong core competencies in cell biology, molecular biology, assay development. We are seeking a qualified candidate who will share our excitement about the science, contribute to our culture, and honor our commitment to patients. Responsibilities: Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. etc.

BioLegend is looking for a Bottling Process Technician for our Formulation Group. This role will be responsible for processing product formulations, filling, capping, labeling, and completing batch records, and putting away Finished Good Inventory (FGI). This is a highly team oriented group which involves working closely with other core teams within the Bottling Department as well as other departments such as Planning, Receiving, Inventory Control, Custom Solution Team (CST), Packaging and Quality Control groups. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Assist in performing various bottling related tasks to include dispensing antibody solutions and capping and labeling of vials, tubes or bottles. etc.

As a Research Associate, you will report to a Senior Scientist or Manager, where you will be able to conduct extensive analysis on new or existing products and consistently report key findings on product research initiatives. Under general supervision and with on-going review, this position researches, designs, develops and/or supports experiments for product development, process optimization applications, analytical methods, and validation activities ensuring a successful transition into a GMP manufacturing environment. The work requires routinely handling small animals and biological samples from animals and human donors. Prior experience in tissue culture, flow cytometry, immunoassays (eg ELISA, immunefluorescent/immune-histochemical staining, Western Blotting,), molecular biology techniques (eg PCR, cloning, etc.), data analysis, and project management are preferred. etc.

The Manufacturing Associate position will function as an important member of the team that manufactures and provides antibodies and reagents to a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. This is a great opportunity for you to enhance your knowledge in the biotechnology industry. Essential tasks for this position include: following Standard Operating Procedures (SOP)s, creating and updating batch records, performing limited buffer preparation, cleaning glassware and restocking lab supplies. Additional responsibilities may also include processing troubleshooting and aliquoting bulk antibodies for finished goods inventory. etc.

As a Filing Operator 1, you will ensure goals are met through the understanding of objectives, communication with co-workers and supervisors, working safely, executing procedures, and ensuring the quality product is being manufactured. Employees are expected to stand for prolonged periods, perform basic mathematical equations, adhere to all verbal and posted guidelines, and be able lift up to 33lbs. Main Accountabilities: Perform packaging activities including but not limited to: label generation, visual inspection, heat sealing, and utilizing packaging equipment. Perform Filling activities in non-controlled areas: tube and bottle manufacturing. Perform routine cleaning tasks in relation to the manufacturing areas. Routinely checking inventory supplies and ensuring all levels are adequate. etc.

Responsible for providing technical support via phone and e-mail to external and internal customers, product support, R&D, marketing and sales group, selling units, distributors and other manufacturers for all QSD products. Includes familiarity with all QSD products, manage and analyze data, work with Customer Contact Report database, Unity/QCNet, and all other supporting programs. etc.

The GMP Manufacturing Technician I position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements as directed by the departmental supervisor, manager or director. To perform this job successfully, an individual must be able to perform each essential function satisfactorily. Essential Functions: Perform manufacturing activities according to written protocols, as directed by the departmental supervisor, manager or director. Maintain batch records, equipment logs and other production records as directed per company procedures. Maintain a clean an orderly laboratory environment. etc.

A Production Technician I, Oligo Liquid Handling is responsible for performing day to day production activities in the custom oligonucleotide (oligo) Liquid Handling lab. Production activities will be performed in a timely fashion and in compliance with company procedures. The Liquid Handling team is responsible for ensuring oligos meet all customer specifications, and final processing prior to delivery to the customer. Areas of Responsibility: Performs all assigned job functions per documented procedures as directed by supervisor. Processes oligo samples in a high throughput production environment using automated Tecan liquid handlers. etc.

Under direct supervision, the Manufacturing Technician I will be responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product. This individual will work independently once they are trained and experienced with technician tasks. Essential Duties & Responsibilities: Perform environmental monitoring and complete documents associated with the activity. Clean and sterilize glassware and other materials. Perform cleaning of cleanroom suites. etc.

The Medical Technologist performs tests requiring the exercise of independent judgment and responsibility in those specialties in which the Technologist is qualified by education, training and experience. In addition, the Medical Technologist is responsible for assuring that a given test system is operated in accordance with the laboratory's procedure manual and that the applicable quality control requirements are met. The incumbent actively supports and complies with all company and departmental policies and procedures. etc.

The Environmental Monitoring Technician will perform Environmental Monitoring (EM) of pharmaceutical cleanrooms and the associated spaces on a daily basis according to FDA, cGMP and Boston Analytical’s/Client Standard Operating Procedures. Primary Duties and Responsibilities: Collects routine daily, weekly and monthly EM samples in pharmaceutical cleanrooms. Sample types include air viable, surface viable, and air nonviable monitoring. Collects compressed gas samples to ensure they are free of microbial and chemical contamination. Samples purified water system at both generation and point of use for subsequent analysis for Bioburden, TOC, Conductivity, and Endotoxin. etc.

The Scientist II conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. The position includes development of analytical methods and attendant procedures, as well as validation of analytical methods, including writing validation protocols and reports. Techniques will include analysis of pharmaceutical products using chromatographic techniques, spectrographic techniques, thermal analysis, and wet chemical analysis. Primary Duties and Responsibilities: Develops methods based on client requirements. Specific techniques include, but are not limited to HPLC, GC, AA, FTIR, and dissolution. Conducts research on manufactured products to develop, improve and validate test procedures. Validates methods compliant with regulatory requirements. etc.

To perform inspection activities on products and to release products to Finished Goods or other release locations; control of products through such activities as inspection of new product lines to Finished Goods, processing shipping holds, processing/controlling pre-release product lines, processing scrap, processing quality records, processing Returns product inspection. Your responsibilities include: Perform inspection activities on products, in such categories as sterility inspection, incoming inspection, in process inspection and returns inspection. Complete data forms with the results of inspection activities, including non-conforming material reports, when required. SAP & WM transactions related to inspection activities. Insure completion of nonconforming reports and update the MRB system. etc.

Primary focus is to build quality product by following processes to meet all production goals. Your Responsibilities Include: Understands and adheres to safety policies and practices. Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP). Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals a8nd metrics. Gains basic understanding of Lean Manufacturing and related principles. Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally. etc.

With general supervisory direction, assist in the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). Your Responsibilities Will Include: Maintenance activities for automated PC and PLC controlled manufacturing equipment. Identify and troubleshoot process, material or equipment problems to minimize down time and improve process yields. Identify, design, and implement process equipment changes to improve reliability of the process. Modify existing and develop new tooling and fixtures. Revise existing documents, processes, and/or methods to correct or improve processes/product. etc.

The Industrial Engineer is responsible for working with key business partners to drive value improvement guided by lean principles to support business strategy and priorities. The Industrial Engineer will also develop/implement continuous process improvement to ensure efficient and cost effective workflows/practices in a light manufacturing and distribution environment. Your responsibilities include: Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes. Coordinate and lead facility layout and design projects within business units. Coordinate and champion value improvement projects throughout the business. Conduct Lean training programs for employees at all leves and departments. Actively deploy and coach the organization on Lean and LBP Essentials. etc.

Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site. Proactively develops and executes recruitment plans that meet and exceed enrollment goals. Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.

The Material Handler supports Production by moving, transferring and pulling orders needed to support Production. The Material Handler performs inventory transactions in Oracle and delivers products to production to complete work orders. Operate Forklift, Walkie Rider, Order selector or pallet jack as needed to provide materials to Production areas

Our Preclinical Sciences group is looking for a Research Associate with a background in Immunology, Cell Biology or a related scientific discipline to join our growing and friendly team during this exciting time in our expansion. Duties include: Human and mouse cell culture and primary cell maintenance and isolation. Design, develop and execute in vitro cell-based immunoassays.

Conduct focused research and development under general direction of supervisor to plan, conduct, analyze, interpret, and report recommendations based on experimental results in routine setting. Develop new sequencing applications, assay workflows and assay automation methods. Plan controlled experiments to characterize key components and finished reagents

As an Engineer 1 in the Research and Technology Development department, you will support the development of novel microfluidic-based sequencing platforms. You will be part of a multidisciplinary team solving complex problems, investigating new research areas and working on integration challenges.

As a Research Associate 2 at Illumina in Systems Integration, you will work in a dynamic, team-oriented environment and help create genomic analysis tools used in the leading edge of research to advance human health by unlocking the power of the genome. Hands-on testing and integration of systems - hardware, software, chemistry, and application components

The primary focus of this position is on routine monitoring and management of the research-related activities at a clinical site. Once fully trained, a Clinical Research Associate will be expected to perform site initiation, periodic, and close-out visits. Additionally, the Clinical Research Associate will be expected to serve as a resource and research liaison between assigned sites and the Sponsoring companies or CROs.

As a Production Technician, you will perform tasks and administrative aspects regarding packaging operations according to department procedures, specifications or work instructions. This includes starting up/breaking down operations, clearing operations areas, calculating component usage, verifying counts of products in and out of operations, and visual inspections of products for defects.

As the Manufacturing Associate, you will perform setup, operation, re-supply, documentation, cleaning, minor equipment adjustments and minor preventative maintenance tasks to meet standards for safety, quality and efficiency. Formulating custom bulk reagents - involves working with pipettes and balances

The primary responsibilities of this role, Production Associate, are to: Embrace and demonstrate a safety-first culture at all times; Perform daily operations as directed by site leadership; Be accountable for safe and timely delivery of quality supply based on production schedules while maintaining an efficient operation; Perform duties in a manner that support overall site Key Metrics including Safety, Quality, TIP (total individual volume performance), TOP (total overall volume performance) and cost efficiency; etc.

The primary responsibilities of this role, Assembler I, are to: Assemble various products; Package various products; Perform rework and inspection on the product; Back up higher-level positions; Have awareness of quality standards and ability to identify defects in products; Record data related to product quality and traceability; Clean of work areas as required; etc.

As a Field Sales representative for Channel, you will be responsible for growing the market share of Seed & Trait business within Northwest Ohio covering the counties of Darke, Mercer, Van Wert, Paulding, Defiance, Henry Putnam, Allen, Auglaize, Shelby, Logan, Hardin, and Union. In this position, you will create demand for Bayer seed growth and Seed & Trait chemistry products through retailers, dealers, and top growers. The primary responsibilities of this role, Field Sales Representative I, are to: Develop and implement dealer business plans, manage forecasting, inventory management and product line demand issues, set the business direction, and coordinate follow-ups with dealers; Serve as the key business consultant to retailers and dealer and effectively sell the value of Bayer crop science products; etc.

Primary Duties and Responsibilities: We are looking for an energetic, dynamic individual to join our team! The ideal candidate will thrive in a fast-paced, high-volume call center environment and whose passion includes the delivery of exceptional, results oriented experiences for our customers and the patients they serve. Handling Customer Calls to facilitate a 7-day Call Center Support Function. You will be expected to rotate holidays and assist in back filling vacation request for your peers. Provide technical resolutions on Hardware, Software, Consumables and LIS related calls from existing customer base through telephone and electronic (i.e. email, fax, remote diagnostics) technology. Possess excellent phone soft skills and communication skills, both verbal and written. Assign calls to field service when unable to resolve over the phone. etc.

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Major Responsibilities: Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. Apply knowledge and experience in specialized areas, with an understanding of the underlying biochemistry. Use that knowledge and understanding to address problems and situations ordinarily encountered in laboratory manufacturing processes. etc.

The CLA I is responsible for assisting with the day-to-day operations and equipment maintenance in the Clinical Laboratory. The CLA I will also be responsible for the pre-analytical phase of testing (e.g., specimen receipt, accessioning, and plasma/buffy coat isolation), performing quality assurance procedures, and complying with all local, state, and federal laboratory requirements. Responsibilities: Perform sample accessioning and isolation procedures according to the laboratory’s standard operating procedures; Clean labware, equipment, and benches; Prepare documents for equipment and personnel records; etc.

We are currently looking for an enthusiastic research associate to join our manufacturing team. This position will entail preparing reagents for our assay kits, QCing, and packaging the finished products. This candidate may also join part time in our R&D team. etc.

The Associate I, Product Development functions with minimal supervision and guidance within the Reagent Research and Development Laboratory. The Associate I conducts product development activities on new and existing products involving Immunohistochemistry (IHC) and in situ hybridization (ISH) procedures within well-defined guidelines. The Associate I keeps abreast of current methodologies and developments within defined areas of research. The Associate I will at times assist other laboratory members or technical staff on research-related activities. etc.

The Associate Scientist I, Product Development functions with minimal supervision and guidance within the Reagent Research and Development Laboratory. The Associate Scientist I conducts R&D activities on new and existing products involving Histology and Immunohistochemistry (IHC) procedures within well-defined guidelines. The Associate Scientist I keeps abreast of current methodologies and developments within defined areas of research. The Associate Scientist I participates in research or clinical collaborative projects. The Associate Scientist I will at times assist other laboratory members or technical staff on research-related activities. etc.

Assist with product development testing tasks and manage assigned lab duties. Essential Duties and Responsibilities: Perform general laboratory related job duties as required. Maintain laboratory equipment logs, stocks solutions and lab supplies. Review and execute test protocols for integration test plan of new and sustaining engineering projects. Enter and update defects in defect management database. Assist with assigned testing and documenting results. Follow all company policies and procedures to ensure product integrity and quality control. Maintains good communication within the team and with other groups involved in the project. etc.

Performs study start up responsibilities by: Performing new award tasks such as entering new studies into the MedComm database, creating Medical Affairs and Medical Communications study-specific folders, organizing study documents, requesting signed Protocols, entering document costs in the new award spreadsheet, and notifying assigned Project Teams. Performing a concise and thorough review of study Protocols related to imaging requirements, schedules and windows. Creating, modifying and finalizing Site Manuals, associated fillable forms, and labels. Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Protocol Amendment Impact Forms (PAIFs), Notes to File (NTFs), Corrections, non-Quality Event Deviation Reports, and Transfers of Obligation (ToO) as required/applicable. etc.

The Research Associate II, Pharmacology is responsible for conducting scientific experiments that contribute to research and drug discovery activities at PTC. This position assists in maintaining multiple mouse colonies, genotyping process, breeding, and conducting behavioral studies The incumbent is also responsible for communicating experimental results to his/her supervisor and the project team. The Research Associate II, Pharmacology supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate. Primary duties/responsibilities: Under general guidance, executes experiments and communicates results as part of multi-disciplinary team(s). Applies relevant scientific principles and techniques to research problems. Maintains detailed laboratory notebooks. Maintains knowledge of state-of-the-art principles and techniques. etc.

The Staff Accountant 1, Accounts Payable responsibilities include processing a full cycle accounts payable, processing travel and expense reimbursements, month end accruals and reconciling designated general ledger accounts. He/She will interface with multiple departments and personnel from within the organization.

We are searching for a highly motivated and team-oriented Clinical Laboratory Technician (CLT) to support a wide variety of molecular biology, biochemical, and extraction techniques to support projects focused on viral infection. Perform specimen processing and accessioning. Perform Automated RNA extraction. Perform PCR-based genetic testing in accordance with standard operating procedures.

Prior experience not required, however, candidates with familiarity with any industrial assembly and/or machine shop equipment such as saws, drills, electronics soldering, and working with small/miniature machined components, will be given preference. Capable of reading and understanding technical specifications of a mechanical capacity.

The Engineering Technician will work to maintain, troubleshoot and repair medical diagnostic instruments, commission new equipment, through quality service and professionalism. We are seeking hard working, motivated, and well-organized individuals with a focus on continuous product improvement to exceed expectations.

This position isresponsible for the evaluationof humanblood products for manual orautomated cell isolations, product manufacturer,andcell culture.Perform QC testing and create a certificateof analysis(COA)for products manufactured. Record isolation details on a processing worksheet usinggood documentation practices. Operate flow cytometer and basic lab equipment.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. Assist in the conduct of clinical studies while providing licensed coverage. Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines.

As a Field Service Engineer, you are responsible for commissioning and calibrating laboratory automation devices to meet internal and customer specifications. As a qualified candidate, you will have mechanical debugging skills, knowledge of machine components, and a basic understanding of liquid handling software. Experience servicing and performing QC on automated liquid handlers is required. You’ll work closely with software and electrical engineers to commission, perform QC and trouble shoot instrumentation in the field. This position will involve travel to customer sites when needed.

The individual in this role will be highly motivated, enthusiastic and brings rigor and a desire to deliver on tasks with focus on the development and scale up of cell-based methods for producing AAV vectors. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the goal to deliver products that transform the lives of patients.

The Analytical Scientist will fulfill a critical role in GMP operations. This individual helps with the execution of feasibility evaluation of analytical methods, method development and validations, writing of validation protocols, reports and other technical quality documents; conducts validation related investigations and contributes to improvements in laboratory operations. Your Tasks: Independently plan and execute validation studies for test methods. Implement and perform analytical method transfer to Quality Control Department. Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. Under minimal supervision, conduct and document investigations related to validation activities. etc.

The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks: Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails. Perform purification process by chromatography, crystallization and other techniques, and in-process test method. Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities. etc.

The Production Technician I performs an integral role as part of the Production team at Bachem. This role is responsible for contributing to the safe and economic manufacture of active pharmaceutical ingredient (API) products, such as peptide or related bioorganic compounds, as a member of a production team. As a Production Technician I, you will be producing APIs from gram to multiple kg scale. The majority of responsibilities will include routine synthetic organic synthesis, the operation of manufacturing equipment and keeping track of batch documentation according to cGMP regulations. etc.

Responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA). ESSENTIAL DUTIES AND RESPONSIBILITIES: Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality. Support the day shift, with requirement to support plant overtime and planned shutdowns when applicable. Provide technical support on product quality issues. Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented. Support timely follow-up on quality exceptions and their preventative/corrective actions. etc.

Responsible for supporting the Engineering department by assisting engineers with the lifecycle development of medical devices, including new product development and maintenance of released products. Essential Duties and Responsibilities: Generate and maintain mechanical models and drawings utilizing computer aided design (CAD) program, according to specifications determined by the engineer. Assist in the testing of design prototypes and support R&D testing activities of assigned products as assigned. Support design changes to develop and improve products as well as facilitate manufacturing operations. Support QA, Manufacturing, Regulatory, Marketing, Suppliers, and Product Management as assigned. Assist with various aspects of the engineering product development process as assigned. etc.

Performs a variety of quality control test and inspection functions on materials, components and finished goods at various stages of the production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products. Essential Duties and Responsibilities: Performs and documents dimensional inspections on inventory parts using engineering prints, Inspection procedures or work instructions. Selects products for tests at specified stages in production process, and tests products for variety of qualities, such as dimensions, performance, and mechanical, electrical, or chemical characteristics. Records test data, applying statistical quality control procedures. May perform, as needed, nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics. etc.

The Research Associate I / II, Drug Substance Process Development (Microbiome) will serve as a key team member in the development and qualification of robust processes for production of human commensal bacteria suitable for use as therapeutic agents. The individual will participate in the design, independent execution of experiments and perform data analysis relating to cell banking, fermentation, harvest, and freeze-drying processes. Execution of analytical testing to support rapid data generation would be desirable. It is expected that the individual will work closely with Research, Drug Product Development, Manufacturing, Analytical Development, Quality Control, and Quality Assurance to ensure timely delivery against team and corporate objectives. (S)he will play an important role in the transfer of formulations and processes as well as facilitating phase-appropriate scale-up operations. etc.

The primary purpose of this role is to support all protein production, purification, and quality control assay needs. This position will work primarily in a laboratory setting with Scientist and R&D teams. If candidate skillset is extended to operational sufficiency with Akta chromatography and Octet kinetic analysis systems then would qualify for Sr. Research Associate role. Essential Job Responsibilities: Culturing and maintenance of established cell lines; transfection of DNA into cell lines for target protein expression. Demonstrated competency with standard protein purification strategies (e.g. protein A, Ni-NTA purification, on-column protease cleavage strategies). etc.

Universal Cells carries out clinical-grade AAV-mediated gene-editing of pluripotent stem cells. The Research Associate I Process Development will work as part of a team evaluating processes, and planning/executing experiments to evaluate all aspects of culturing, gene-editing, and processing of pluripotent stem cells. The Research Associate will be formally trained and will perform all fundamental skills including record keeping, general lab skills, equipment use and maintenance, aseptic technique/cell culture, and basic troubleshooting. They will assist with projects and lead day-to-day activities based on abilities. They will keep appropriate documentation, including lab notebooks, batch documentation and experimental summaries. etc.

We are seeking a motivated and enthusiastic Research Associate or Sr Research Associate to join our Protein Engineering group. The successful candidate will play a key role in further developing our yeast display platform and applying it to engineer antibodies and bispecifics. Duties & Responsibilities: Culture yeast and perform flow cytometry assays. Sort libraries by FACS and help with NGS sample preparations (plasmid prep and PCR). Help develop methods for selecting yeast-displayed antibodies bound to cancer cells. Follow laboratory safety guidelines and practices. etc.

This an entry-level position within our mammalian protein purification group. The ideal candidate will be responsible for purification and characterization of a variety of protein types including therapeutic proteins, antigens and assay reagents expressed in mammalian cells. They will not be satisfied with just doing their part, but will thrive on being part of a collaborative team that aims to continually improve. Proteins will be purified at various scales ranging from high throughput robotic purification to many grams. Additionally, the incumbent will have opportunities to learn cell culture, bacterial and yeast fermentation in addition to bioanalytical techniques. etc.

With general supervisory direction, you will be responsible for performing support functions for manufacturing operations, including troubleshooting equipment and process issues, and performing and documenting machine maintenance procedures. Additionally, it is expected that you will partner with engineering in developing methods and procedures to control or modify manufacturing processes. Your Responsibilities Will Include: Identify and troubleshoot process, material or equipment problems to minimize down time. Perform preventative maintenance and calibration procedures, as well as author equipment maintenance and calibration procedures. Modify existing and develop new tooling and fixtures. Revise existing documents, processes, and/or methods to correct or improve processes/product. etc.

Your Responsibilities Include: Understands and adheres to safety policies and practices. Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP). Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals a8nd metrics. Gains basic understanding of Lean Manufacturing and related principles. Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally. Under the direction of other maintains accurate records such as Manufacturing Execution System (MES), Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP) and Process Equipment Optimization (PEO). etc.

With general supervisory direction, you will be responsible for performing support functions for manufacturing operations, including troubleshooting equipment and process issues, and performing and documenting machine maintenance procedures. Additionally, it is expected that you will partner with engineering in developing methods and procedures to control or modify manufacturing processes. Your Responsibilities Will Include: Identify and troubleshoot process, material or equipment problems to minimize down time. Execute validation plans and compile data. Collect data and perform basic statistical analysis for process characterization and scrap reduction goals. etc.

Collaboratively design and conduct plant phenotyping assays to determine treatment efficacy. Conduct molecular analyses of gene expression using PCR and RT-qPCR. Sow and maintain plants under a variety of conditions in chamber and greenhouse settings

Plan & perform routine molecular biology techniques such as PCR, DNA subcloning, in vitro transcription, cell transformation, cell culture, protein expression & purification, nucleic acid isolation as well as more advanced methods in support of research projects. Execute experiments and associated analytics (such as enzyme assays) at different scales (ranging from 10s of µLs to 10s of Ls) for debottlenecking & optimization and

This position is responsible for performing quality assurance functions in the laboratory, including the review of test records, reviewing records, monitoring employee practices, assessing activities for compliance to procedures, and keeping management informed of any quality concerns related to the laboratory operator.

Provide a positive customer experience by providing health information as per standard operating procedure (SOPs) or as directed by the center Medical staff , explaining fees schedules and bonus programs, instruct donors regarding the importance of plasma donation and explains the uses of the products made from donated plasma.

Our ideal Donor Center Technician is a stand out colleague who is patient, can handle multiple tasks, and adapt to a dynamic work environment. Conducts pre-donation medical screening in accordance with established guidelines. You determine Hematocrit (HCT) and Protein via finger stick and use of the hematastat and refractometer.

The Clinical Research Associate l (CRA) is responsible for monitoring activities that will lead to successful execution of IVD clinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA engages with internal and external stakeholders as a member of the Clinical Trial Operations team.

CSA is responsible for receiving and responding to all types of communication: phone, email and web inquiries from customers (physician offices, laboratories, and hospitals), sales representatives and patients. Adhering to Standard Operating Procedures (SOP’s) pertaining to data entry and data verification requirements

Operate and troubleshoot a variety of machinery. Operate the worksaver and standup/sitdown lifts as needed. Utilize manlifts. Perform line changeovers, which include cleaning, disassembly, re-assembly of line equipment and lubrication. Comply with and support the GSK Environmental, Health and Safety policies and procedures.

Responsibilities include: reagent preperation, molecular biology work, experiments with aseptic cell cultures and protein pruification. Other responsibilities include completing appropriate documentation of experiments including laboratory notebooks, equipment logbooks and inventory forms, preparation of technical reports, summaries, protocols and quantitative analyses with minimal supervision.

Ensuring appropriate cGMP documentation is generated, revised, approved and maintained. Reviewing associated documentation and labeling for accuracy and completeness. Verifying lot acceptance results for adherence to specification, limits or other acceptance criteria. Approving these results, as required

Supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing. Performs sampling of water pure steam to support manufacturing activities. Performs Environmental Monitoring of aseptic filling rooms and supporting areas.

Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management. Follow production and manufacturing procedures. Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.

The Associate, QC - Microbiology role will perform environmental monitoring, various testing, equipment troubleshooting/maintenance, and may assist with the drafting of SOPs, protocols, and reports to support manufacturing operations. Organizes daily workload and relevant resource requirements in an efficient manner. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in a fast-paced, highly interactive, goal-oriented team environment with minimal supervision. etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the TULSA, OK territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the BOISE, ID territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

The company’s U.S. entity, Amarin Pharma Inc., is seeking a Sales Professional for the Sarasota, FL territory. The Sales Professional meets established sales goals in promoting Vascepa to general practitioners, specialists and other healthcare professionals in compliance with internal policy and applicable laws/regulations. The Sales Professional will be supported in this initiative with tools and promotional resources designed to have high local impact. The successful professional will achieve sales goals and demonstrate the ability to target and manage their territory strategically while operating within an assigned budget (and adhering to all compliance and administrative duties). etc.

Major Responsibilities: Provide training to new employees on cGMP concepts, SOPs, Batch Record execution, Batch record reviews, and Investigations. Basic understanding and knowledge of techniques, instrumentation, and lab functions to identify problems and support the completion of work assignments. Review proposed SOP revisions and provide feedback to management. Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters. etc.

Primary Responsibilities: Must manage and organize the glass cleaning operation according to approved standard operating procedures. Must manage time well. Must be able to perform daily tasks in a timely manner – improving productivity while minimizing idle time. Follow approved GMP manufacturing directions such as standard operating procedures and other instructions in support of production. Responsible for documenting all production operations in logbooks and/or batch records. Perform the scheduled clean room cleaning activities as described by the standard operating procedure. etc.

A technical position involving equipment repairs and maintenance activities intended to keep the facility equipment (i.e. process, utility, and general equipment) within compliance of cGMPs. Essential Duties and Responsibilities: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Perform Preventative Maintenance Tasks: Follow written PM procedures. Accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health and safety requirements. Perform PM of all types of plant equipment including coordinating access to equipment working around customer’s needs. etc.

Duties: Perform analytical chemistry analyses in accordance with company SOPs and protocols following cGMP guidelines. Log-in samples. Work with potent chemical reagents and standards. Summarize data into reports. Ability to multi-task. Performs special projects as assigned. Test and analyze samples within the specified turn-a-round time. etc.

In this role, you will: Conduct laboratory operations in a safe manner. Maintain familiarity with the Chemical Hygiene Plan. Exhibit safety awareness and safe work practices. Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels, as well as all appropriate SOP’s. Develop and maintain working knowledge of commonly used spectroscopic and physiochemical procedures. Analyze samples with the standard procedures effectively and under minimal supervision. Analyze experimental data for validity before reporting results. Keep contemporary, accurate, legible, and complete experimental records in accordance with GMP and GLP practices. etc.

In this role, you will; Assist with developing and validating test methods based on relevant ISO, ASTM standards and or client requirements. Independently perform tests per ISO, ASTM, and/or client requirements. Perform testing within the specified test plan and/or SOP for each test. Monitor projects for conformance with applicable SOPs and test specifications. Prepare test specimens for package/material/device testing. Manage multiple projects/tests at any one time ensuring all commitments are met. Collaborate with and train other laboratory staff on a project basis as appropriate. Document results and review data. etc.

Research Scientist I in Albany, NY AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Research Scientist I is an integral part of the AMRI team, contributing to our success by the synthesis, purification and identification of intermediates and target compounds. The Research Scientist I is expected to demonstrate expertise in both the theoretical and practical aspects of organic chemistry. In this role, you will: Synthesize compounds efficiently using literature or in-house notebook procedures. Purify synthesized chemicals to an appropriate degree. The scientist will be able to use the full range of chromatographic, crystallization, and distillation techniques. etc.

Triage and resolve incidents, problems, and requests efficiently using our ITSM tool. Configure, install, and troubleshoot software, laptops, desktops, IP phones, mobile devices, printers, and other computer peripherals. Provide timely support onsite, remotely, and over the phone as part of our global IT call center. Perform after-hours work as needed on a rotating schedule. Procure standardized hardware and software from vendors, escalating non-standard requests to leadership. Follow change procedures for employee events (new hires, terminations, transfers, promotions, etc.). Assign roles and permissions to network resources such as SharePoint sites, file shares, and ERP systems. etc.

Assembly of Percutaneous Endoscopic Gastrostomy (PEG) devices or products using like materials/components/assembly procedures. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Hand assembly and gluing of components. Use of manual and semiautomatic fixtures. Inspection of assembled components. Maintain quality and efficiency standards. Complete paperwork accurately and legibly. Cross-functional training required. etc.

Operates injection molding machines according to specific schedules and procedures. Prepares mold inserts and reviews molded component integrity. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Remove molded components from the mold once the machine has finished its cycle. Prepare cores and mold for next cycle. When applicable test parts during machine cycle to predetermined specifications. Inspect parts for overall integrity while machine is cycling. Maintain quality and efficiency standards. Use of manual and semiautomatic fixtures. Complete paperwork accurately and legibly. etc.

Assembly of feeding sets and other basic assemblies or products using like materials/components/assembly procedures. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned. Visual inspection of devices, labels, and packaging. Use of manual and semiautomatic fixtures. Inspection of assembled components. Maintain quality and efficiency standards. Complete paperwork accurately and legibly. Cross-functional training required. etc.

Job performance will involve a variety of activities including: Execution of work instructions for testing raw materials, in-process materials/sub-assemblies, and top-level IVD materials to determine compliance to specifications. Critical analysis of data ensuring compliance with standards and specifications. Generation of data reports. Adherence to safety and quality laboratory standards. Upkeep of personal training and associated records. Maintenance of laboratory material stocks and initiation of re-orders. Execution of method validation and stability testing protocols. Identification of non-conforming material and subsequent report initiation and generation (OOS/OOT investigation). etc.

The purpose of this position is to transfer product and process knowledge from developmental clinical production to GMP product manufacturing in the drug product manufacturing division of Argonaut. Responsibilities: Facilitate transfer of new processes from client lab or concept to drug product manufacturing by collaborating with subject matter experts and operations management. Participate in client discussions via phone, video conference, and/or onsite visits. Create and revise client-specific batch records, raw material specifications, and any documentation related to Drug Product Manufacturing. Review executed batch records and other documentation, as needed. etc.

Arthrex Manufacturing is hiring additional team members to the Textile department on second shift. The Textile Technician is responsible for setting and operating machines that produce the materials for the Sutures department. The second shift hours are 4:00 pm to 12:30 am, Monday through Friday. Training will be on first shift for approximately 8 weeks. The job location will be at the Arthrex manufacturing facility in Ave Maria, FL. Essential Duties and Responsibilities: Set-up and operate a variety of hand tools and light duty textile machines to manufacture product specified on work order using engineering prints, standard work instructions and Inspection procedures. Manufacture the finished product to specifications with the use of measuring equipment, specialized hand tools and microscopes, making decisions in equipment setup parameters within established guidelines to achieve the required specifications. etc.

The Technician is responsible for the re-manufacture and repair activities of linear accelerators (linacs) that allow Accuray to provide products that meet customer needs and do so in accordance with regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: Performs CNC machining operations in the Linac Repair Center. Performs precision Tungsten Inert Gas (TIG) welding of copper, Kovar, and stainless steel. Investigates field returns to decide what the failure was and what actions need to be taken for repair. Assembles and disassembles linear accelerators in accordance with schedule and in accordance with quality system requirements, procedures, and work instructions. Uses Rf equipment for tuning of linear accelerators. etc.

This is an entry level position for a Biotechnician. Employee will carry out manufacturing practices in a cGMP biotechnical facility. The job involves the manual processing of porcine urinary bladders, which includes all aspects from collection of raw materials to packaging of the final product. Following training, work will be expected to be performed independently to a high degree of standard in biomaterial handling. Principal Responsibilities: Collection of raw materials. Rinse and initial cleaning of raw materials upon receipt. Separation and removal of unwanted tissues. Disinfection. Preparation of storage and cleaning solutions. etc.

The Clinical Laboratory Technologist 1 position will be responsible for processing medically relevant biological samples through extraction or high throughput DNA sequencing assays. This role will work within a team of Laboratorians in a fast-paced, high production setting to process research and clinical diagnostic samples to provide a test result to patients, oncologists and other medical practitioners and researchers. As such, high attention to detail and clinical mindedness are crucial to success in this role. Responsibilities: Assignment to one of two labs performing either DNA extractions from human biological samples, or PCR amplification and high-throughput sequencing assays on DNA libraries. Demonstrate good clinical judgment and integrity. Perform DNA extractions, PCR amplification or high-throughput sequencing assays on DNA libraries. etc.

The essential job function is to support the development and validation of analytical methods for raw materials, work-in-process, and finished products and to provide testing support for the formulation development and clinical supplies release process. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following. Other duties may be assigned. With supervision and direction the analyst is required to: Provide support for the development and validation of pharmaceutical analytical methods for potency, dissolution, impurities/degradation products, residual solvents…using appropriate laboratory instrumentation e.g. HPLC, UHPLC, LC-MS, Dissolution Apparatus, GC… etc.

The QC Analyst Microbiology will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viables in support of cGMP manufacturing which includes several production suites of ISO class 5, 7, and 8 as well as EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Additional responsibilities may include EM data review and compilation of data, report writing, and trending of data; investigations, gowning training and annual gowning qualification. etc.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Responsibilities: Essential Duties: Prepares compounded sterile products using aseptic technique. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed. Participates in cleanroom product introduction activities. Prepares records and monitors results for pharmaceutical quality assurance testing. etc.

Responsibilities: Essential Duties: Under the direction of the PMO Manager, supports the Project Management Office (PMO) related activities to ensure the success of the PMO and its objectives. Works collaboratively in a team environment (Corporate, Manufacturing, Quality, Operations, Supply Chain, Procurement, Engineering, etc.) in support of PMO activities. Collaborates with Project Leaders to update and manage the project portfolio data and capital spend and forecast data via spreadsheet and the project portfolio management system (PPMS). Supports the creation and maintenance of key project portfolio metrics using Excel, Powerpoint, and other tools to provide visibility to management. etc.

The Calibration Technician is responsible for the following activities: Ability to perform all Calibration Technician I functions. Ability to work independently installing, troubleshooting, and calibrating all types of instruments or control systems in any Akorn environment. Maintain calibration records and enter calibration data using software such as Calibration Manager. Daily review and update the calibration validation data. Fluently use software such as MS Excel, Word, and other maintenance manager software such as AMMS to purchase items and complete validation documentation. Develop SOPs for new or existing equipment as required. Coordinate equipment calibrations for equipment to be calibrated. etc.

Direct oversight of assigned production fill room, equipment preparation or glassware preparation employees. Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems. Must be able to communicate effectively with all levels of employees. Must be able to perform simple math calculations. Must be able to solve problems, handle conflict, and make effective decisions under pressure. ESSENTIAL LEAD TECHNICIAN DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned. Provide oversight of the Key Process Steps; i.e., equipment set up and alignment, defined line speed, hold times, machine prime, etc. In addition: Media fill completed in strict adherence to the Batch Record and Media SOP requirements. etc.

The Environmental Monitoring Technician I will perform all environmental monitoring tests required to monitor the manufacturing controlled areas at Akorn’s Grand Avenue facility. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Must be able to demonstrate and apply good aseptic technique and cleanroom behavior. Must be able to demonstrate and apply good gowning technique during certification, re-certification, and routine monitoring. Must be able to understand the operation and application of all monitoring devices that are automated or manual operation in the department. Must be able to demonstrate the ability to monitor and document all environmental parameters, such as viable sampling, personnel sampling, temperatures, humidity, and differential pressures under static and dynamic conditions. Fill out cleanroom information sheets. etc.

Prepare documents, reports for managers. Schedule and coordinate meetings, travel arrangement. Data processing, input and verification. Monitor and track expenses

Perform work within the manufacturing department to clean equipment/rooms, dispense, and operate equipment for product studies, development, and commercial production.

In this position, you will need to analyze specimens and review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations.Maintains laboratory in a clean, functional state, as well as cleaning, performing or scheduling equipment and instrument maintenance/calibration/certification, as required

We’re looking for highly talented and motivated research associates to join our high-throughput screening (HTS) team and help carry out these critical functions. High-throughput culturing of microbial strains using a variety of automated solutions for use in high-throughput screens. Creation of strain libraries through the execution of a HTP transformation and colony picking workflows.

Position Summary: Performs a wide variety of electronic, mechanical, or electro-mechanical assembly operations on assemblies or sub-assemblies. Sets up and operates automatic or semi-automatic machines. May perform other tasks including, but not limited to; placing labels on packages, and putting data sheets with product. Main Responsibilities: Assembles, repairs, inspect and/or test products following written instructions. Ability to read and comprehend basic instructions and other work related documents, written in English. Sets up and operates a variety of manufacturing machines or equipment following written instructions in the English language. etc.

Postmarket Surveillance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering). The other role of the Postmarket Surveillance Analyst is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; etc.

We are seeking a Research Associate for our Quality Control team to test a wide variety of antibody-based products in our Eugene, OR facility. The core responsibility will be to provide support to the quality control team by testing our catalog of products after they have completed the manufacturing process. These products include quantity ELISA kits, activity ELISA kits, Western blot antibodies, immunocytochemistry antibodies, and flow cytometry kits. Primary Responsibilities: Perform documented methods required for finished product quality testing. Review manufacturing documentation for process deviations. Communicate analyzed results in detailed written reports. etc.

The successful candidate will be responsible for conducting experiments to support client-based processes with a focus on vaccine Downstream cell culture processes. This position will work with a team of scientists and technical specialists responsible for process development and technology transfer to ensure the application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Contributes to operations of development team, and may support tech transfer activities as necessary. Responsibilities: Work according to defined protocols on defined biopharmaceutical projects for development and/or characterization of vaccine downstream manufacturing processes. Execute lab-scale experiment in supporting downstream process development, verification, characterization. etc.

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology Division. We’re seeking a highly motivated Research Associate I to join the team. Responsibilities: Assist with in vivo pharmacology experiments for preclinical contract research. Perform in vivo studies to evaluate anti-cancer efficacy of test agents in tumor mouse models with supervision. Monitor mouse groups enrolled in drug efficacy, mechanism of action, PKPD and proof-of-concept studies. Perform drug dosing by various routes of administration. Perform in-life blood sampling through various routes. etc.

X-Chem Pharmaceuticals is seeking candidates for the position of Research Associate / Senior Research Associate, Lead Discovery. X-Chem is a drug discovery company that uses DNA-encoded library (DEL) technology to discover leads for therapeutic targets. As a world leader in DEL technology, X-Chem collaborates with numerous pharmaceutical and biotechnology companies, resulting in over 70 licensed programs to date. Key Responsibilities: Determine suitability of constructs for affinity-mediated discovery processes. Use X-Chem’s DNA-Encoded Chemical Library technology to support a range of external projects. Assist in the interpretation of selection output data. Communicate observations, interpretations and conclusions internally and externally. etc.

Yokogawa is seeking to hire a Service Project Engineer. PRIMARY TASKS: Successfully execute multiple, small to moderate projects to the defined scope, within budget, on schedule, and to the satisfaction of the customer (internal and external). Conducts systems operational test. Installs system hardware/software upgrades as required. Manage and review the drawing package ACAD documentation. Review vendor submittals, prepare factory and other purchase orders, track orders, and receive materials per the project schedule and scope. Troubleshoot existing systems on-line and support network / subsystem testing. Provide regular updates on work in progress, immediate notification of issues related to quality, cost, or schedule, and propose solutions as problems arise. etc.

This position is responsible for operating process equipment and following all site operating, Quality, cGMP, and safety procedures associated with manufacturing of bulk medicated feed additives (MFA) from raw material to finished product. Incumbent must be able to clearly and frequently communicate with various functions within the site, including production, maintenance, quality operations, fermentation development, and administration. This is a 3rd shift position for the hours of 10:00 pm – 6:00 am. POSITION RESPONSIBILITIES: Selects and weighs components in accordance with established manufacturing directions (batch records). Selects and moves components to weighing area or dumping station. Examines finished products to determine consistency and blend characteristics. Samples products according to Quality Control procedures. Selects and records lot number and weights of all materials, reconciles weights and yields on batch formulation sheet. etc.

Provide technical guidance on issues/projects within Manufacturing or Quality. Coordinate the engagement of the Global Manufacturing Technology (GMT) organization as needed. Identify and drive continuous process improvements. Lead large scale investigations for the site. Identify and implement cost savings initiatives for the site. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Zoetis Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Position Responsibilities: Take the manufacturing/quality lead in the introduction of new processes or modifications to existing processes as supported by Global Manufacturing Technology (GMT). Assist in performing technical evaluations and implementation of GMT initiatives to ensure robust process improvements and transfers. etc.

Work as part of a team operating pharmaceutical packaging lines. Operate packaging equipment and other related tasks. Maintain accurate and concurrent documentation of all tasks completed. Maintain a positive attitude and be able to work well with others in a team environment. Demonstrate good attendance. Position Responsibilities: Record Keeping and Documentation: Maintain and complete accurate records (time cards, batch records, log books, etc.). Equipment: Operate assigned equipment, i.e. . PLC controlled packaging line, vision system, etc. Clean production equipment and facilities. Set-up/ disassemble production equipment. Operate specific in-process devices associated with the equipment, i.e. moisture analyzers, pH meters, etc.

We are seeking formulation scientist to support development of new veterinary drug products and reformulation of existing products. The formulation scientist will be responsible for characterization of candidate molecules for the development of appropriate dosage forms for clinical and commercial needs. This is an exciting opportunity where scientist will have full ownership on formulation research in early stages as well as often late stage development. The scientist will be expected to support interdisciplinary teams of colleagues from Discovery, clinical development, safety, regulatory, marketing and global manufacturing, with technical expertise. On occasion, the scientist will be expected to lead PharSci team and bring forward the drug product, analytical methods and drug supplies for drug candidates from early discovery stage to commercialization. Working on veterinary medicine, the scientist will have opportunity to work on the development of oral, topical, parenteral and other delivery routes. etc.

Responsibilities include routine testing to support product release, raw material release, and cleaning verification. The technician will rely on experience and judgment in order to plan and accomplish goals. Routine testing of samples supporting incoming raw materials, in-process production, finished product, and validation. Utilize LIMS for data entry and test recording

This individual holding the position of QC Technician II shall be responsible for performing routine testing of in-process and finished product samples, raw material, stability, and utilities. They shall be responsible for monitoring the environmental conditions in the laboratory and in manufacturing areas. They shall support validation projects. This position must be available to work overtime as assigned.

Performs Method Transfers/method verifications/Co-Validations of testing procedures utilized within the Quality Control Laboratory. Prepares testing documentation or progress reports on projects and recommends course of future action. Acts as liaison between the Product Development, Stability, and the QC Chemistry Laboratories for the transfer and implementation of new procedures.

Responsible for providing technical support to operations in terms of equipment/system requalifications/ qualifications. Will perform studies as part of equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also perform HEPA filter integrity/velocity testing and participates as hands-on work in critical area (class 100) airflow pattern testing.

May support technical transfer of client project in and to manufacturing as applicable. Summarizes and report data. Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness. Supports capital projects by providing technical expertise. Supports new project site-fit assessments as needed

Review of QC analytical testing for GMP in-process, release and stability testing as needed: pH, Osmolality, Conductivity & qPCR, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assays, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred. Review technical transfer, qualification and validation protocols as needed.

Assist with quality control analytical testing of samples provided to the QC laboratory. Assist with executing test qualification and validation of QC test methods. Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation

Inside sales to white space and vacant territory business planning/support. Develop and maintain strong working relationships with target HCPs (via telephone, video conference and in person). Deliver approved, education-focused messages, as well as the assigned therapeutic area disease-state information to target HCPs (via telephone, video conference and in person).

The Product Development Engineer will contribute to all phases of product design, development and support. Technical competencies in the areas of biomedical engineering, electrical engineering and mechanical engineering are required. Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, software development, EC’s and CAPA

A Clinical Assistant is responsible for a wide variety of clinical and clerical duties to support the Stool Donation program. The Clinical Assistant works under the general supervision of the Nursing and Supervising clinical staff is responsible for following Standard Operating Procedures to ensure the safety of stool donations. The Clinical Assistant will work collaboratively with donor operations staff and other departments to ensure strict adherence to standard operating procedures and maintain constant communication with clinical staff.

Develop, optimize and perform assays using molecular biology procedures and technologies including qPCR, quantitative western blots, ELISA. In vitro culture of cancer cell lines and primary cells as well as DNA/RNA isolation from blood/tissue is required. Assist in the management of preclinical and clinical samples internally and with third party providers.

Foxx Life Sciences is facing overwhelming demand for our products and is seeking entry-level, full-time, hourly WarehouseAssociates to assist with specific, daily functions within general manufacturing and assembly. There will be future possibilities for promotions as the company grows. All training is provided,and prior experience is not required for consideration.

We are seeking a highly motivated, organized individual with demonstrated competencies/ability to learn new cell-based assays quickly. The successful candidate will join the fast-growing, vibrant Biology Team. She/he will be conducting innovative research in the discovery pipeline, aiding the advancement of several key programs through method development for both in vitro and in vivo studies. These activities particularly include differentiating iPSC lines for in vitro lung disease-modelling and drug screening studies. The environment nurtures innovation, and encourages career growth, therefore the individual will have the opportunity to learn a range of novel cell and molecular biology techniques. etc.

The Analytical Research and Development (AR&D) Scientist performs laboratory analyses in the testing of raw materials, in process (IP), finished products (FP) and stability (ST) samples following Analytical Methods, Protocols, Standard Operating Procedures (SOPs) and company policies. Collaborating closely with, and under the direct supervision of, Senior AR&D Scientists and AR&D Managers the incumbent carries out laboratory work to support AR&D activities and performs special projects as assigned. She/he also carries out laboratory work to support product development and method development. Carries out responsibilities in accordance with the organization’s policies, SOPs, and state, federal and local laws. Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC,), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus. etc.

Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Core Responsibilities: Perform microbiological assays for in-process and final product samples. Perform analytical methods for final bulk material/finished goods. Test and disposition of raw materials and perform environmental monitoring. Review of QC data for compliance to procedures and specifications. Calculate and evaluate results. Participate in lab maintenance and administration duties. Initiate lab investigations and deviations. Lab support including but not limited to glass washing, autoclaving, etc. Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities. etc.

The Quality Inspector/Technician is responsible for determining if product manufactured conforms to specified requirements. This shall be accomplished by inspecting, monitoring and releasing to established acceptance criteria. This position shall also ensure that quality related functions, procedures and policies established are adhered to. POSITION REQUIREMENTS: Conduct first article inspection for start-up processes. Conduct in-process inspection of manufacturing and assembly processes. Conduct final inspection (AQL) for lot release. Communicate with Lead Inspector and production personnel on non-conformances found. Coordinate retained parts with proper identification. Audit production operations. etc.

Vor Biopharma is seeking a motivated Associate Scientist to join our Cancer Immunotherapy group. This individual will be independent, goal-oriented, technically competent, and able to efficiently in a team setting. We are searching for enthusiastic, innovative, and inquisitive individuals with deep scientific background in immunology, cancer immunotherapy, and/or autoimmune diseases, who are comfortable working in a fast-paced entrepreneurial environment. Key areas of responsibility: Work closely with a diverse team of scientists to drive key cancer immunotherapy projects forward. Design and execute experiments for in vitro, in vivo, and ex vivo immune studies. Phenotyping immune populations, sample preparation, and analysis for in vivo studies. Data analysis and proper electronic notebook record keeping. Communication of experimental plans and data within the team. etc.

Wright Medical is hiring a Hub Material Handler I in Philadelphia, PA . The Hub Material Handler I is responsible for making pickups and deliveries of implants and instruments to and from local hospitals, surgery centers, clinics/doctor’s offices, the airport, bus station, and other locations for expedited shipments. Excellent communication must be maintained with adaptability to the needs of the customers, sales management/reps, and both corporate and office personnel to ensure timely transportation of goods for surgical procedures. This position has responsibilities to be the liaison between the field office and Wright Medical customers for coordinating activities relating to the efficient use of company assets. A positive and professional approach is required with very strong communication skills to ensure a flawless delivery for surgery. etc.

The Process Engineer prepares GMP documentation such as batch/cleaning records, equipment qualification protocols, campaign reports, etc. for the Pilot Plant and Kilo Lab. Prepares QA documents such as SOPs/TWIs to ensure cGMP compliance. Evaluates and improves current procedures and equipment in the Pilot Plant. Interacts with QA, QC, Process R&D, Materials Management, EH&S, Facilities, and Purchasing to optimize and execute manufacturing campaigns. Assists with the execution of GMP and non-GMP production in the Pilot Plant and Kilo Lab. Performs safety testing (DSC, RC-1, TSU, etc.) and other tests to collect and analyze data for project support. etc.

Performs entry level specialized computer numerical control (CNC) machinist work for Structure Medical, LLC. Operates CNC machines to run production per approved schedule provided. Work is performed under close supervision with minimal latitude for the use of initiative and independent judgment. Responsible for setting up and operating CNC machines; performs preventative maintenance on machines. Notifies the CNC Programmer of problems with equipment and/or tooling that may cause defects or lost time. Recommends process improvements to resolve problems. Fills out proper paperwork per job. etc.

We are currently seeking a highly motivated and enthusiastic BioProcess Engineer to contribute to development of fermentation and downstream processes for manufacturing of our engineered probiotics. The successful candidate will be part of a dynamic and motivated development team, helping to bring Synlogic’s novel synthetic biotics to clinical trials and eventual commercialization. HOW YOU WILL CONTRIBUTE: Lab operations to support microbial fermentation process development, optimization, and validation. Support and perform fermentations in benchtop bioreactors, high throughput fermentation systems (AMBR250, AMBR15), and large-scale single-use fermenter systems. etc.

Reporting to the Associate Director, join the Assay Development group in the R&D division. We are a team of outstanding, dedicated scientists. We are seeking talented, motivated and driven individuals to join a collaborative effort to enable development of rapid diagnostic tests. This opportunity is in the fields of molecular diagnostics and leverages our proprietary microfluidic system. This position is an opportunity for the appropriate candidate to further develop independent thinking, creativity and leadership. You will develop additional menu(s) for our system. etc.

What you’ll do: Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Utilize automation and robotics to standardize the discovery pipeline from sample acquisition to sequencing output. Maintain quality metrics and data generation for next-generation sequencing platforms. Work to maintain CLIA/CAP compliance in a novel field. etc.

Responsibilities and Duties: Adhere to and follow laboratory established procedures for processing, analyzing and reporting patient samples. Follow laboratory established quality control policies and protocols in recording readings, note deviations and document all corrective actions taken when deviations occur. Be capable of identifying problems that may affect test performance and turnaround time and immediately bring it to supervisor, Director, or Medical directors’ attention. Be proficient in a wide range of routine and complex assays performed at AKESOgen with appropriate training. Be willing to run automated Nucleic Acid instrumentation, real time PCR, DNA/RNA spectrometer, genetic scanners, and other instruments with appropriate training. Assist in performing proficiency testing as required. etc.

Responsibilities and Duties: Adhere to and follow laboratory established procedures for processing, analyzing and reporting patient samples. Follow laboratory established quality control policies and protocols in recording readings, note deviations and document all corrective actions taken when deviations occur. Be capable of identifying problems that may affect test performance and turnaround time and immediately bring it to supervisor, Director, or Medical directors’ attention. Be proficient in a wide range of routine and complex assays performed at AKESOgen with appropriate training. Be willing to run automated Nucleic Acid instrumentation, real time PCR, DNA/RNA spectrometer, genetic scanners, and other instruments with appropriate training. Assist in performing proficiency testing as required. etc.

Responsibilities and Duties: Adhere to and follow laboratory established procedures for processing, analyzing and reporting patient samples. Follow laboratory established quality control policies and protocols in recording readings, note deviations and document all corrective actions taken when deviations occur. Be capable of identifying problems that may affect test performance and turnaround time and immediately bring it to supervisor, Director, or Medical directors’ attention. Be proficient in a wide range of routine and complex assays performed at AKESOgen with appropriate training. Be willing to run automated Nucleic Acid instrumentation, real time PCR, DNA/RNA spectrometer, genetic scanners, and other instruments with appropriate training. Assist in performing proficiency testing as required. etc.

As a Part-time Process Assistant (M-F 7-11PM) you will be helping our lead lab technicians sorting samples, making measurements, calculating amount and dispensing micro fluid while logging electronic record. Previous experience working in a molecular biology lab setting is preferred but not required. If you are interested to work in the Bio/Pharma industry, this will be a good entry position.

Perform lab-scale downstream processing of vaccine products and process intermediates. Perform assays on vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests. Prepare solutions/reagents. Set-up process equipment for lab-scale experiments

Environmental, Health, Safety, Quality (EHSQ) Compliance. Process/equipment and areas of operating responsibility. Completes building equipment safety inspections. Monitors and coordinates building waste recovery and disposal activities. Inventories and orders designated building supplies.

The Patient Financial Services Associate I (PFSAI) position is responsible for the accurate and timely processing of claims, appeals, denials, and statements for Exact Sciences. A PFSAI demonstrates medical insurance knowledge by resolving billing discrepancies, eligibility, denials, appeals, and aged unpaid claim follow up for commercial, government, and plan coverage for optimal Account Receivable (AR) outcomes.

The QA Operations team provides direct support for all manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals. Review of batch records during active manufacturing. Perform routine manufacturing area line clearances

The responsibilities of a Quality Technician are to assist in receiving and inspecting raw materials, intermediates and products used in scientific research. Duties may require document and product reconciliation, inventory management (electronic), and assisting with complaint investigations. Employees must have the ability to work independently and as a part of a team environment.

You will be responsible for assisting in the Clinical Controls Product Finishing Department with the bottling operation and the other activities involved in the product finishing process. Cap vials or tubes, operate the torqueing equipment. Assist department in maintaining inventory of vials, tubes, closures, Styrofoam trays and dividers.

Process incoming shipments from suppliers, ensuring accuracy of all product data. Aliquot product into vials and assemble kits for customer orders and global stocking. Work with colleagues across the business to resolve discrepancies quickly. Maintain accurate inventory levels using both manual and automated systems.

The successful candidate will provide commercial and inside sales support for the rest of the team including outbound prospecting, handling inbound leads, qualifying opportunities and connecting the prospects with the outside sales team. This person will have a basic understanding of molecular biology and NGS applications and the ability to engage with potential users of our software.

Support Manufacturing and Packaging Operations under cGMP conditions. PRINCIPAL DUTIES AND RESPONSIBILITIES: Account for inventories and move material using pallet jacks. Weighing, metal detecting and blending of product. Set up equipment to run product to specification. Fill hoppers with raw materials. Load components (bottles, cartons, cups, booklets, shippers) onto machines. etc.

The ideal candidate will have a passion for animal welfare and a great work ethic. Hard-working individuals looking for a great environment and a chance to make a difference will fit right in. Your primary role will be taking care of our animals and sanitizing their housing and our buildings. This may include caring for rats, mice, rabbits, dogs, cats, swine, or even cattle! There may be some heavy lifting and some dirty work involved but, if you love the idea of spending your day with animals, it's worth it to take care of our little heroes. etc.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Operates saws (band/cut-off) to produce quality parts based on provided specifications. Operates washers and rinse tanks. Performs simple CNC/manual mill and lathe setup/operations within product families to produce quality parts based on provided specifications. Operates manual and/or CNC mills and lathes to produce quality parts based on provided specifications. Cleans machines and remove chips. Performs basis preventative maintenance on machines. Performs routine dimensional and visual inspection of product per procedure, specification or print using basic measuring equipment (caliper, micrometer, scale, indicators, SPC equipment). etc.

The Finisher II will perform finishing techniques such as buffing, polishing, grinding, deburring and etching on machine products. Achieve proper size, finish and quality following drawings and quality specifications. Performs routine visual inspection and also uses basic measuring equipment. etc.

Responsible for the review and remediation of existing technical files to ensure the Packaging requirements meet the EU MDR regulations. Working with general supervision from the Senior Packaging Engineer, designs and develops packaging components and packaging systems for new and existing medical device products and/or product lines (sterile and non-sterile). Significant opportunity for individual action. Reports to the MDR Work Stream Leader of Labeling Operations & Global Packaging Technology, via the Senior Packaging Engineer Lead. etc.

Summary: The OSC II Operation Service Center Specialist is the senior OSC who coordinates schedules, prepares and ensures delivery of instruments and implants sets for surgery. They are responsible for maintaining accurate records of products as they flow through the territory. Accountability of products missing from sets is critical to ensure proper billings. Good working knowledge of company products, operating systems and procedures is critical. This position provides guidance and training to the OSC I position to ensure all requirements are performed for the OSC position. etc.

This individual will contribute to providing microbiological support and testing of cGMP environments, as well as contribute to in-process, drug substance, and drug release testing. ESSENTIAL DUTIES AND RESPONSIBILITIES: Environmental monitoring of cGMP cleanrooms per FDA and USP guidelines. Sampling of utilities (i.e. water, clean compressed air). Input and manage environmental data. Conduct QC testing of raw materials and utility samples; QC tests include, but not limited to bioburden, endotoxin, total organic carbon, conductivity, osmolality, and pH. etc.

The Materials Associate's responsibilities are divided into three primary functional areas: shipping and receiving, inventory accountability, and other duties. Shipping and Receiving: Primary responsibility are shipping and receiving domestic as well as international packages. Responsible for incoming inspection of all materials. Inventory Accountability: Create and maintain inventory records and forward to appropriate departments. Issue supplies, materials and equipment to workers and ensure that all corresponding paperwork is accurately managed. Perform physical inventory inspections to ensure 100% of inventory accuracy. etc.

This position is responsible for performing/controlling a combination of manual or automated tasks necessary for the receipt, storage, and shipment of product. This may include functions of receiving, picking, packing, shipping, staging, transporting, storage, delivery, etc. How you make a difference . . . you will . . . Load and or unload materials using proper methods and procedures for securing materials. Receive, select and prepare materials for relocation to end users. Ensure accuracy of shipments and supporting documentation, receiving incoming material and routing to appropriate area or personnel, filling work orders, packaging assemblies and receiving into finished goods, ensuring inventory transaction are accurately logged and overseeing cycle counts and reconciliation activities. etc.

This position operates vial wash/packaging production equipment. Position is responsible to supply assigned positions with materials/items to complete work and according to standard operating procedures. Position is also responsible to clean equipment, production areas, and inspect parts/items following prescribed procedures. Provides troubleshooting on basic issues and may assist in providing training. How you make a difference . . . you will . . . Operates all assigned equipment appropriately and per established methods and procedures, to include set up, operation and cleaning of equipment and parts, confirming configurations are correct, checking for leaks or other abnormalities or anomalies, ensuring proper communication of any issues or problems immediately, complete operational documentation per SOP, and tagging/palletizing/placement of all returned and rejected items as needed and required. etc.

At STERIS, our Field Service Technicians act as the face of our company by ensuring top-notch service for our customers. In this field-based, customer-facing role, you will travel to hospital and surgical facilities to maintain, troubleshoot, service, and provide calibration and installation support for steam sterilizers, medical equipment washers and other STERIS products as needed. In addition, you will be responsible for building positive relationships with customers and colleagues, as well as completing necessary administrative tasks. Transferable skills for this role include mechanical (large military/agricultural equipment, appliances or vehicles), plumbing, HVAC, electrical, building maintenance and other similar field service repair work. etc.

The primary role of the Repair Technician is to perform repairs on medical instrumentation. Technicians will be trained to become familiar with various types of surgical instruments and understand how to best maintain and repair them. Repairs are completed on a repair truck onsite at a hospital or surgery center. In addition to repair work, Technicians may work with a team including Sales Representatives and RCs (Repair Consultants/Managers) to identify and capitalize on revenue opportunities. Travel requirements may vary by location. etc.

At STERIS, our Field Service Technicians act as the face of our company by ensuring top-notch service for our customers. In this field-based, customer-facing role, you will travel to hospital and surgical facilities to maintain, troubleshoot, service, and provide calibration and installation support for steam sterilizers, medical equipment washers and other STERIS products as needed. In addition, you will be responsible for building positive relationships with customers and colleagues, as well as completing necessary administrative tasks. Transferable skills for this role include mechanical (large military/agricultural equipment, appliances or vehicles), plumbing, HVAC, electrical, building maintenance and other similar field service repair work. etc.

Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing

ou will work closely with various teams to ensure efficient operations of daily activities and drive continuous improvement efforts of products and processes. Technologies you will be working with include but are not limited to, Google Cloud Platform, Amazon Web Services, Microsoft Azure, Kubernetes, Docker, Jenkins, Terraform & Ansible.

The Rebate Associate is responsible for analyzing customer and product utilization data and other deliverables to inform stakeholders of market share performance and to alert Finance, Brand, Contracting and Forecasting Managers to issues that require revenue management attention. In addition, the Rebate Associate will prepare quarterly and/or monthly payment packages, per the applicable contract, providing detailed analyses and reports, and submit for review and approval up through the highest levels of EMD Serono Management.

Wearing of appropriate protective gear, (hard hats, glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protection equipment "PPE" to protect themselves from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles. The work area may occasionally be wet, humid abnormally hot or cold. Siting, standing, walking, reaching above the shoulder, stooping, kneeling, twisting, crouching or crawling for long periods of time.

The Associate Production Scientist is a critical role in the safe and efficient manufacturing of APIs according to cGMP requirements. Demonstrate proper lab safety practices, and work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines. Working in a team environment, and being an effective member of a project team (PD through Production)

As a Laboratory Operator II, you will be responsible for high fidelity execution of detailed protocols. Operators are relied on for the immediacy and reliability with which experiments are run on the ECL, so attention to detail is crucial. The Lab Ops team relentlessly clears the queue of customer experiments and keeps the robots in the labs running at all times, with a focus on exactness and increasing efficiency. The entire ECL facility is run in a systematic way, and the team purview encompasses all protocols that enable this, from maintenance and control of instruments to inventory intake.

Perform WFI sampling and testing as per current protocol, or validation protocols to support the WFI system. Perform sampling of raw materials. Clean the laboratory glassware using dishwasher or manually washing, if necessary. Perform daily laboratory tasks, such as balance calibration checks, temperature chart monitoring, CSR duties, etc.

Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)

This position is responsible for the timely and efficient scheduling and packaging of standard and custom products, and for providing support to other areas of manufacturing to ensure timely product delivery. Assist in all packaging and labeling operations for Manufacturing. Assist in cGMP material inspection and receiving raw materials for Manufacturing.

RESPONSIBILITIES: Tissue culture facility management: biosafety cabinet and incubator maintenance, cell line expansion, mycoplasma testing, banking, and confirming loss-of-function or gain-of-function gene mutations by sequencing, qPCR, immunoblotting, and functional assays. Utilize CRISPR/Cas9 genome editing and other cell biology tools to generate and characterize cell line models. Aid in the execution CRISPR-enabled genome-wide SL screens with other scientists. Production and management of lentiviral stocks. Management of biology lab inventory (ordering, stocking, and organizing). etc.

The company is seeking an entry-level marketing person available immediately. We are seeking a fast-pace individual with experience in internet-driven social network marketing strategies with focus on use of Linkedin and Twitter to generate leads. Candidates must be located in San Diego, CA. Experience in internet-based and email-based marketing strategies is needed. Experience with website design, WordPress, email marketing and design, and SEO strategies are a plus. Ideal candidate should have some scientific background to be able to understand and implement novel strategies, evaluate competition, customer’s needs, and the services provided by the Company. Compensation will be based on commissions generated from new revenue. etc.

The Research Assistant will be an active member of our dynamic Research Team. The Research Team leads target/enzyme-based projects for biotech and pharma clients to develop biochemical assays for high-throughput screening and characterization of drug candidates and reaction mechanisms. Responsibilities include: Support preparation of reagents and materials for running biochemical assays. Assist in executing biochemical assays utilizing state of the art mass spectrometry. Integrate automated liquid handling and support compound management. etc.

The Quality Analyst is responsible for performing Quality Assurance (QA) oversight of GMP compounding activities at SCA Pharmaceuticals. The Quality Analyst assists system owners in performance of non-conformance investigations, executes CAPA’s as they pertain to the QA department and supports validation and technical change control activities. This position requires advanced understanding of site processes in order to write technical documents including engineering studies and standard operating procedures. The position is a non-management position. The individual occupying it is expected to be capable of working with minimal supervision. The Quality Assurance Analyst is expected to communicate well with fellow Quality Assurance employees as well as Operations and Pharmacy departments. etc.

The Translational Sciences department is seeking a highly motivated and creative research associate to assist with critical reagent discovery and bioanalytical assay development. This work will support the advancement of multiple antibody-drug conjugate (ADC) and immuno-oncology biotherapeutics from late-stage research into clinical development. The successful candidate will have experience in standard and exploratory bioanalytical techniques that can be used to characterize the pharmacokinetics, pharmacology, biodistribution, and/or stability of antibody-based drugs. etc.

Business Intelligence Analysts (BIA I & II) play a meaningful role in achieving our team’s goal of exceeding customers’ expectations with leading edge data management and data-driven insights and applications. A Glimpse of What Your Day-to-day will look like: Design, develop and administer a system for self and others to evaluate appropriateness of data for analytic hypotheses and applications. Develop and direct a process to clean and integrate complex healthcare datasets in order to create the data foundation for further analytics, client applications, and the development of key client insights. Contribute client team meetings for client engagements and strategic projects requiring complex data management support. etc.

We are seeking a researcher to join a team focused on the expression and purification of human expressed proteins. The successful candidate will support the development and optimization of processes that produce cytokines and growth factors. These proteins will be used in cell therapy and stem cell research. Key Responsibilities: Maintain various cell lines for multiple projects. Expand cell lines for production. Work in a team environment with senior scientists and production scientists. etc.

The Technical Associate Kit Assembly operations must comprehend and perform assigned automated and manual production tasks according to established Standard Operating Procedures (SOP’s). Responsible for Automated and/or Manual production and assembly procedures in compliance with relevant regulations and SOP’s. Adhere to and accurately complete all production-related documentation. Responsible for set up, trouble shooting and operation of automated production equipment, as well as other production related equipment within the assembly area. etc.

Position Description: Must comprehend and perform assigned manual and automated kit assembly production tasks per established standard operating procedures (SOP). Support the label printing area printing labels as needed. Use computers, label printing and counting equipment to print / verify labels and perform all labeling related duties. Operate, maintain, and troubleshoot automated label printing and counting equipment. Operate, maintain, set up and trouble shoot manual manufacturing assembly equipment as described by production area SOPs. etc.

The Technical Associate in EZ1 Manual Filling/Assembly comprehends and performs assigned manual vialing of components under general supervision as well as using automation in the production of finished product. Responsible for manual and automated production and packaging procedures in compliance with relevant regulations and Standard Operation Procedures. Potential, for additional responsibilities with buffer production, weighing and addition of raw materials. Adhere to and accurately complete all production-related documentation. etc.

The Protein Purification Technician I performs assigned manufacturing and process development duties in a ISO 13485 environment. Job performance will involve a variety of activities including: Execute development and production scale purification protocols as directed. Work with standard scientific equipment as described in relevant procedures; AKTA Purifier and AKTA Pilot, UV spectrophotometer, balances, chromatography columns, SDS-PAGE, autoclaves, pH meter, refrigerators, freezers, biohazard safety cabinets. etc.

The Associate Quality Engineer is responsible for owning and coordinating Quality Engineering functions and activities for the defined processes. This position is also responsible for supporting the Production, Quality Control, Engineering and Quality Assurance departments and the associated activities, which include receiving inspection, in-process inspection, and finished goods inspection in achieving and exceeding company goals and objectives. In addition, this role is responsible for supporting the administration, implementation, and continuous improvement of the quality systems associated with non-conforming materials, inspection control plans, and corrective/preventive action. The Associate Quality Engineer supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, product and process improvement projects, product qualifications and failure investigations for product complaints. etc.

Project managers coordinate between our clients, our project leads, our senior project management and director of contract research. They act as the advocate for the client to the team and the advocate of the team to the client.Project managers become experts in all of our discovery technologies, and communicate the status of projects to clients as they progress.